Fibromyalgia
Conditions
Brief summary
This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Interventions
DRUGPlacebo
Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
DRUGPregabalin
Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 VAS * 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 * Patients with suicidality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 15 or study discontinuation | Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index | Baseline, Week 15 or study discontinuation | MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline. |
| Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint | Week 15 or study discontinuation | MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night. |
| Change From Baseline in Sleep Quality Score at Endpoint | Baseline, Week 15 or study discontinuation | Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC) | Week 15 or study discontinuation | PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health | Baseline, Week 15 or study discontinuation | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety | Baseline, Week 15 or study discontinuation | Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition. |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression | Baseline, Week 15 or study discontinuation | Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition. |
| Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | Baseline, Week 15 or study discontinuation | The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness | Baseline, Week 15 or study discontinuation | FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. |
Countries
Japan
Participant flow
Pre-assignment details
Participants were administered placebo tablet in single blind manner and evaluated for the inclusion/exclusion criteria during the 1-week screening phase. Participants who demonstrated a high response to placebo, i.e., \<=30% decrease on the VAS, were discontinued from the study at the end of the screening phase.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo was administered twice a day for 15 weeks. | 248 |
| Pregabalin Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase. | 250 |
| Total | 498 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 24 |
| Overall Study | Lack of Efficacy | 26 | 10 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Not meeting entrance criteria | 2 | 5 |
| Overall Study | Other | 2 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Pregabalin | Total |
|---|---|---|---|
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 years | 21 Participants | 24 Participants | 45 Participants |
| Age, Customized Between 18 years and 44 years | 104 Participants | 101 Participants | 205 Participants |
| Age, Customized Between 45 years and 64 years | 123 Participants | 125 Participants | 248 Participants |
| Sex: Female, Male Female | 217 Participants | 226 Participants | 443 Participants |
| Sex: Female, Male Male | 31 Participants | 24 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 113 / 248 | 195 / 250 |
| serious Total, serious adverse events | 0 / 248 | 1 / 250 |
Outcome results
Primary
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | -1.03 Scores on a scale | Standard Error 0.12 |
| Pregabalin | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | -1.48 Scores on a scale | Standard Error 0.12 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.004695% CI: [-0.78, -0.11]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain | 9.50 Scores on a scale | Standard Error 1.06 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain | 11.65 Scores on a scale | Standard Error 1.06 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.07795% CI: [-0.81, 5.1]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception | 2.83 Scores on a scale | Standard Error 0.85 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception | 4.66 Scores on a scale | Standard Error 0.85 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.064895% CI: [-0.54, 4.19]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health | 3.33 Scores on a scale | Standard Error 0.98 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health | 5.97 Scores on a scale | Standard Error 0.98 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.028795% CI: [-0.08, 5.37]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning | 4.72 Scores on a scale | Standard Error 0.93 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning | 9.01 Scores on a scale | Standard Error 0.93 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.000695% CI: [1.7, 6.88]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional | 3.50 Scores on a scale | Standard Error 1.36 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional | 3.27 Scores on a scale | Standard Error 1.35 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.54895% CI: [-4, 3.54]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical | 8.36 Scores on a scale | Standard Error 1.3 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical | 10.04 Scores on a scale | Standard Error 1.3 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.180595% CI: [-1.93, 5.29]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning | 6.84 Scores on a scale | Standard Error 1.38 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning | 8.43 Scores on a scale | Standard Error 1.37 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.206895% CI: [-2.23, 5.41]ANCOVA
Secondary
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality | 5.12 Scores on a scale | Standard Error 1.22 |
| Pregabalin | Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality | 9.53 Scores on a scale | Standard Error 1.21 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.005295% CI: [1.04, 7.8]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious | -0.64 Scores on a scale | Standard Error 0.16 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious | -0.92 Scores on a scale | Standard Error 0.16 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.101195% CI: [-0.72, 0.15]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression | -0.51 Scores on a scale | Standard Error 0.14 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression | -0.55 Scores on a scale | Standard Error 0.14 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.416595% CI: [-0.44, 0.35]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good | -0.82 Scores on a scale | Standard Error 0.17 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good | -1.45 Scores on a scale | Standard Error 0.17 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.005295% CI: [-1.12, -0.15]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework | -1.00 Scores on a scale | Standard Error 0.15 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework | -1.32 Scores on a scale | Standard Error 0.15 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.072995% CI: [-0.74, 0.11]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning | -0.97 Scores on a scale | Standard Error 0.15 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning | -1.56 Scores on a scale | Standard Error 0.15 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.002395% CI: [-1.01, -0.18]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain | -1.06 Scores on a scale | Standard Error 0.15 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain | -1.46 Scores on a scale | Standard Error 0.15 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.023895% CI: [-0.81, 0]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function | -0.19 Scores on a scale | Standard Error 0.11 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function | -0.47 Scores on a scale | Standard Error 0.11 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.037695% CI: [-0.59, 0.03]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness | -0.90 Scores on a scale | Standard Error 0.15 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness | -1.05 Scores on a scale | Standard Error 0.15 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.256895% CI: [-0.57, 0.29]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness | -0.94 Scores on a scale | Standard Error 0.14 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness | -1.43 Scores on a scale | Standard Error 0.14 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.007595% CI: [-0.89, -0.1]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores | -7.26 Scores on a scale | Standard Error 1.08 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores | -10.59 Scores on a scale | Standard Error 1.07 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.014495% CI: [-6.31, -0.35]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss | -0.30 Scores on a scale | Standard Error 0.15 |
| Pregabalin | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss | -0.31 Scores on a scale | Standard Error 0.15 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.476895% CI: [-0.42, 0.4]ANCOVA
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety | -0.09 Scores on a scale | Standard Error 0.18 |
| Pregabalin | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety | -0.57 Scores on a scale | Standard Error 0.18 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.026295% CI: [-0.97, 0.01]ANCOVA
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression | 0.00 Scores on a scale | Standard Error 0.2 |
| Pregabalin | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression | -0.29 Scores on a scale | Standard Error 0.2 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.156195% CI: [-0.83, 0.27]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | -3.02 Scores on a scale | Standard Error 1.36 |
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | -8.01 Scores on a scale | Standard Error 1.36 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.004995% CI: [-8.77, -1.21]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index | -7.07 Scores on a scale | Standard Error 0.96 |
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index | -10.06 Scores on a scale | Standard Error 0.95 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.013795% CI: [-5.65, -0.33]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep | 0.17 Scores on a scale | Standard Error 0.06 |
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep | 0.46 Scores on a scale | Standard Error 0.06 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.000795% CI: [0.11, 0.47]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy | 8.02 Scores on a scale | Standard Error 1.41 |
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy | 15.50 Scores on a scale | Standard Error 1.4 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: <0.000195% CI: [3.58, 11.38]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | -8.13 Scores on a scale | Standard Error 1.31 |
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | -17.62 Scores on a scale | Standard Error 1.31 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: <0.000195% CI: [-13.12, -5.85]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | -1.61 Scores on a scale | Standard Error 1.33 |
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | 3.37 Scores on a scale | Standard Error 1.33 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.995895% CI: [1.29, 8.68]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence | -4.66 Scores on a scale | Standard Error 1.29 |
| Pregabalin | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence | 6.65 Scores on a scale | Standard Error 1.28 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 195% CI: [7.74, 14.87]ANCOVA
Secondary
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | -14.11 Scores on a scale | Standard Error 1.45 |
| Pregabalin | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | -20.30 Scores on a scale | Standard Error 1.44 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.001395% CI: [-10.2, -2.18]ANCOVA
Secondary
Change From Baseline in Sleep Quality Score at Endpoint
Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.
Time frame: Baseline, Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Sleep Quality Score at Endpoint | -0.79 Scores on a scale | Standard Error 0.12 |
| Pregabalin | Change From Baseline in Sleep Quality Score at Endpoint | -1.52 Scores on a scale | Standard Error 0.12 |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: <0.000195% CI: [-1.06, -0.4]ANCOVA
Secondary
Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.
Time frame: Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint | 53 Participants |
| Pregabalin | Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint | 71 Participants |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.p-value: 0.068795% CI: [0.9, 2.35]Regression, Logistic
Secondary
Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC)
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.
Time frame: Week 15 or study discontinuation
Population: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC) | 62.1 Percentage of participants |
| Pregabalin | Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC) | 70.0 Percentage of participants |
Comparison: The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.p-value: 0.0078Chi-squared