Back to resultsRandomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Pregabalin
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00830167
First Posted
January 26, 2009
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00830167
Brief Title
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Official Title
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
498 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Pregabalin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
Description
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
Secondary Outcome Measure Information:
Title
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)
Description
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
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance
Description
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
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring
Description
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
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache
Description
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
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep
Description
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
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy
Description
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
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence
Description
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
Title
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index
Description
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
Title
Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
Description
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
Title
Change From Baseline in Sleep Quality Score at Endpoint
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious
Description
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
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality
Description
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
Title
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health
Description
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
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Description
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
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression
Description
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
Title
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ichihara-shi
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yotukaidou
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Matuyama-si
State/Province
Ehime
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka-shi
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Iiduka
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitakyusyu
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kobe
State/Province
Hyougo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Mito
State/Province
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Morioka
State/Province
Iwate
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sagamihara-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koushi
State/Province
Kumamoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiki-gun
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama-city
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Aoi-ku
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shimotsuga-gun
State/Province
Tochigi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuou-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Itabashi-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toyama-shi
State/Province
Toyama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagano
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26694975
Citation
Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
Results Reference
derived
PubMed Identifier
23062189
Citation
Ohta H, Oka H, Usui C, Ohkura M, Suzuki M, Nishioka K. A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia. Arthritis Res Ther. 2012 Oct 12;14(5):R217. doi: 10.1186/ar4056.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081208&StudyName=Randomized%2C%20Double-Blind%2C%20Placebo-Controlled%20Study%20Of%20Pregabalin%20In%20Patients%20With%20Fibromyalgia
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
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