Fibromyalgia
Conditions
Keywords
Pregabalin, fibromyalgia
Brief summary
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
Interventions
DRUGpregabalin
Pregabalin capsule, 300-450mg/day, twice daily
DRUGplacebo
Placebo, twice daily
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients, at least 18 years of age * Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites) * At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS) * At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4
Exclusion criteria
* Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1) * Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia * Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders * CLcr less than 60 mL/min (estimated from serum creatinine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | Baseline, Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 | Baseline, Week 14 | The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment. |
| Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder. |
| Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder. |
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute. |
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute. |
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute. |
| Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute. |
| Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | Baseline, Week 14 | The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. |
| Change From Baseline in Mean Sleep Interference Score at Week 14 | Baseline, Week 14 | The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes \[unable to sleep due to pain\]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1. |
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO) | Baseline, Week 14 | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. |
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO) | Baseline, Week 14 | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. |
| Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Week 14 | The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. |
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST) | Baseline, Week 14 | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. |
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality | Baseline, Week 14 | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14 | Baseline, Week 14 | The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant's level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment. |
| Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score | Baseline, Week 14 | The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status. |
| Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score | Baseline, Week 14 | The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status. |
| Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14 | Baseline, Week 14 | The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 no pain to 100 worst possible pain. |
| Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score | Baseline, Week 14 | The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment. |
| Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score | Baseline, Week 14 | The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Baseline to Follow up (Day 105) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs. |
| Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | Baseline to Follow up (Day 105) | A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function. |
| Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO) | Baseline, Week 14 | The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. |
Countries
China
Participant flow
Pre-assignment details
A total of 431 participants were screened and 343 of these were randomized. A total of 334 participants received the assigned study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.
Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening. | 170 |
| Placebo Placebo matched to pregabalin 75 mg (1 capsule) was administered twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase. Placebo was then administered as matched to pregabalin 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with placebo matched to pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.
Number of capsules taken daily with placebo matched the number taken for the assigned pregabalin dose level. | 164 |
| Total | 334 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 23 | 11 |
| Overall Study | Lack of Efficacy | 8 | 6 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | No longer meets eligibility criteria | 0 | 1 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 5 |
| Overall Study | Randomized, not treated | 3 | 6 |
| Overall Study | Withdrawal by Subject | 13 | 14 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 11.5 | 43.5 years STANDARD_DEVIATION 10.6 | 44.0 years STANDARD_DEVIATION 11.1 |
| Primary Diagnoses and Durations Fibromyalgia duration since diagnosis | 0.3 years STANDARD_DEVIATION 1 | 0.4 years STANDARD_DEVIATION 1.2 | 0.3 years STANDARD_DEVIATION 1.1 |
| Primary Diagnoses and Durations Fibromyalgia duration since onset of symptoms | 6.0 years STANDARD_DEVIATION 7 | 5.6 years STANDARD_DEVIATION 6.4 | 5.8 years STANDARD_DEVIATION 6.7 |
| Sex: Female, Male Female | 142 Participants | 144 Participants | 286 Participants |
| Sex: Female, Male Male | 28 Participants | 20 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 170 | 47 / 164 |
| serious Total, serious adverse events | 0 / 170 | 9 / 164 |
Outcome results
Primary
Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | -2.01 Units on a scale | Standard Error 0.148 |
| Placebo | Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | -1.28 Units on a scale | Standard Error 0.15 |
p-value: 0.000195% CI: [-1.1, -0.36]Mixed-effects model repeated measures
Secondary
Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score
The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score | -1.03 Units on a scale | Standard Error 0.287 |
| Placebo | Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score | -0.65 Units on a scale | Standard Error 0.292 |
p-value: 0.293495% CI: [-1.09, 0.33]ANCOVA
Secondary
Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score
The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score | -1.11 Units on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score | -0.28 Units on a scale | Standard Error 0.294 |
p-value: 0.022695% CI: [-1.54, -0.12]ANCOVA
Secondary
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Quantity of Sleep | 0.61 Units on a scale | Standard Error 0.089 |
| Pregabalin | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Somnolence | -1.29 Units on a scale | Standard Error 1.311 |
| Placebo | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Quantity of Sleep | 0.32 Units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Somnolence | -5.48 Units on a scale | Standard Error 1.337 |
Comparison: Statistical analysis for quantity of sleep.p-value: 0.010695% CI: [0.07, 0.51]ANCOVA
Comparison: Statistical analysis for somnolencep-value: 0.011295% CI: [0.96, 7.43]ANCOVA
Secondary
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score | -11.45 Units on a scale | Standard Error 1.608 |
| Placebo | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score | -8.02 Units on a scale | Standard Error 1.636 |
p-value: 0.0995% CI: [-7.39, 0.54]ANCOVA
Secondary
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score | -9.70 Units on a scale | Standard Error 1.307 |
| Placebo | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score | -6.64 Units on a scale | Standard Error 1.334 |
p-value: 0.063795% CI: [-6.29, 0.18]ANCOVA
Secondary
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Snoring | 4.61 Units on a scale | Standard Error 1.748 |
| Pregabalin | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Awaken Short of Breath | -6.76 Units on a scale | Standard Error 1.809 |
| Pregabalin | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Sleep Adequacy | 14.23 Units on a scale | Standard Error 1.94 |
| Placebo | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Snoring | 2.08 Units on a scale | Standard Error 1.777 |
| Placebo | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Awaken Short of Breath | -4.41 Units on a scale | Standard Error 1.842 |
| Placebo | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Sleep Adequacy | 5.20 Units on a scale | Standard Error 1.99 |
Comparison: Statistical analysis for snoring.p-value: 0.248595% CI: [-1.77, 6.83]ANCOVA
Comparison: Statistical analysis for awaken short of breath.p-value: 0.299395% CI: [-6.81, 2.1]ANCOVA
Comparison: Statistical analysis for sleep adequacy.p-value: 0.000395% CI: [4.21, 13.85]ANCOVA
Secondary
Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score
The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score | 2.68 Units on a scale | Standard Error 0.831 |
| Placebo | Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score | 2.30 Units on a scale | Standard Error 0.846 |
p-value: 0.714995% CI: [-1.67, 2.43]ANCOVA
Secondary
Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score
The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score | 4.44 Units on a scale | Standard Error 0.538 |
| Placebo | Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score | 3.66 Units on a scale | Standard Error 0.548 |
p-value: 0.244295% CI: [-0.54, 2.11]ANCOVA
Secondary
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality | 1.59 Units on a scale | Standard Error 0.166 |
| Placebo | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality | 0.82 Units on a scale | Standard Error 0.169 |
p-value: 0.000395% CI: [0.35, 1.18]Mixed-effects model repeated measures
Secondary
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO) | -0.26 Minutes | Standard Error 0.052 |
| Placebo | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO) | -0.28 Minutes | Standard Error 0.053 |
p-value: 0.808295% CI: [-0.12, 0.15]Mixed-effects model repeated measures
Secondary
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO) | -0.95 Awakenings | Standard Error 0.094 |
| Placebo | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO) | -0.30 Awakenings | Standard Error 0.095 |
p-value: <0.000195% CI: [-0.89, -0.41]Mixed-effects model repeated measures
Secondary
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST) | 24.63 Minutes | Standard Error 5.851 |
| Placebo | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST) | 17.23 Minutes | Standard Error 5.958 |
p-value: 0.338895% CI: [-7.76, 22.55]Mixed-effects model repeated measures
Secondary
Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO) | -42.36 Minutes | Standard Error 5.92 |
| Placebo | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO) | -25.19 Minutes | Standard Error 6.01 |
p-value: 0.027395% CI: [-32.42, -1.92]Mixed-effects model repeated measures
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14
The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 | -11.14 Units on a scale | Standard Error 1.343 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 | -8.15 Units on a scale | Standard Error 1.367 |
p-value: 0.076295% CI: [-6.3, 0.32]ANCOVA
Secondary
Change From Baseline in Mean Sleep Interference Score at Week 14
The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes \[unable to sleep due to pain\]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Mean Sleep Interference Score at Week 14 | -1.88 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Mean Sleep Interference Score at Week 14 | -1.00 Units on a scale | Standard Error 0.153 |
p-value: <0.000195% CI: [-1.26, -0.5]Mixed-effects model repeated measures
Secondary
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14
The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant's level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14 | -4.09 Units on a scale | Standard Error 0.676 |
| Placebo | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14 | -3.25 Units on a scale | Standard Error 0.681 |
p-value: 0.318695% CI: [-2.5, 0.82]ANCOVA
Secondary
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14
The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 no pain to 100 worst possible pain.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14 | -17.04 Units on a scale | Standard Error 1.922 |
| Placebo | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14 | -13.43 Units on a scale | Standard Error 1.952 |
p-value: 0.133295% CI: [-8.34, 1.11]ANCOVA
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs.
Time frame: Baseline to Follow up (Day 105)
Population: The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 119 Participants |
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 Participants |
| Pregabalin | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Discontinuation due to AEs | 22 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 103 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 9 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Discontinuation due to AEs | 11 Participants |
Secondary
Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity
A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function.
Time frame: Baseline to Follow up (Day 105)
Population: The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | Mild AEs | 183 Events |
| Pregabalin | Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | Moderate AEs | 52 Events |
| Pregabalin | Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | Severe AEs | 38 Events |
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | Mild AEs | 162 Events |
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | Moderate AEs | 30 Events |
| Placebo | Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity | Severe AEs | 25 Events |
Secondary
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14
The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.
Time frame: Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Very much worse | 0.0 Percentage of participants |
| Pregabalin | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Very much improved | 9.9 Percentage of participants |
| Pregabalin | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Much improved | 25.4 Percentage of participants |
| Pregabalin | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Minimally improved | 40.1 Percentage of participants |
| Pregabalin | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | No change | 17.6 Percentage of participants |
| Pregabalin | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Minimally worse | 4.9 Percentage of participants |
| Pregabalin | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Much worse | 2.1 Percentage of participants |
| Placebo | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Very much worse | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | No change | 24.6 Percentage of participants |
| Placebo | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Very much improved | 7.7 Percentage of participants |
| Placebo | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Much worse | 2.1 Percentage of participants |
| Placebo | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Much improved | 19.7 Percentage of participants |
| Placebo | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Minimally worse | 3.5 Percentage of participants |
| Placebo | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Minimally improved | 42.3 Percentage of participants |
Comparison: Statistical analysis performed for PGIC endpoint re-categorized into much/very much improved and other.p-value: 0.139795% CI: [0.8732, 2.3667]Cochran-Mantel-Haenszel
Comparison: Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other.p-value: 0.15195% CI: [0.8596, 2.4886]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | 47.5 Percentage of participants |
| Placebo | Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | 32.7 Percentage of participants |
p-value: 0.004495% CI: [1.2007, 2.9827]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | 27.2 Percentage of participants |
| Placebo | Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | 17.0 Percentage of participants |
p-value: 0.018995% CI: [1.1151, 3.4742]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index.
Time frame: Baseline, Week 14
Population: The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Pregabalin | Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | 41.2 Percentage of participants | 41.2 |
| Placebo | Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | 43.6 Percentage of participants | 43.6 |
p-value: 0.676795% CI: [0.67, 1.87]Regression, Logistic