FibromyalgiaPhase 3NCT00830167
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
A Phase 3 study testing Pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 35 sitesJapan
- Study dates
- Mar 2009to May 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with other severe pain conditions
- Patients with severe depression
- Patients taking excluded medications
- Patients with suicidality
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Japan35 sites
Pfizer Investigational Site
Aoi-ku, Shizuoka
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chiyoda-ku, Tokyo
Pfizer Investigational Site
Chuou-Ku, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Hiki-gun, Saitama
Pfizer Investigational Site
Ichihara-shi, Chiba
Pfizer Investigational Site
Iiduka, Fukuoka
Pfizer Investigational Site
Kitakyushu, Fukuoka
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Koushi, Kumamoto
Pfizer Investigational Site
Matuyama-si, Ehime
Pfizer Investigational Site
Mito, Ibaraki
Pfizer Investigational Site
Morioka, Iwate
Pfizer Investigational Site
Nagano
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Ōita
Pfizer Investigational Site
Osaka
Pfizer Investigational Site
Sagamihara-shi, Kanagawa
Pfizer Investigational Site
Saitama, Saitama
Pfizer Investigational Site
Saitama-shi, Saitama
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Setagaya City, Tokyo
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Shimotsuga-gun, Tochigi
Pfizer Investigational Site
Shinagawa-Ku, Tokyo
Pfizer Investigational Site
tabashi City, Tokyo
Pfizer Investigational Site
Takasaki, Gunma
Pfizer Investigational Site
Tokushima
Pfizer Investigational Site
Toyama, Toyama
Pfizer Investigational Site
Tsu, Mie-ken
Pfizer Investigational Site
Yokohama, Kanagawa
Pfizer Investigational Site
Yokohama
Pfizer Investigational Site
Yotukaidou, Chiba
About this study
Official title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia
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.
- Conditions
- Fibromyalgia
- Being tested
- Placebo, Pregabalin
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
PregabalinDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Pregabalin | Experimental | Not described Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 15 or study discontinuation
Secondary outcomes (32)
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.
Measured: Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
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.
Measured: Baseline, Week 15 or study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830167
- Sponsor's protocol ID
- A0081208
- Status last verified
- Apr 2012
- First submitted
- 26 Jan 2009
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26694975Ohta 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.
PubMed 23062189
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00830167
- Acronym / sponsor ID
- A0081208
- Conditions
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Posted 1 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Pregabalin | Experimental | Drug: Pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients with other severe pain conditions
- Patients with severe depression
- Patients taking excluded medications
- Patients with suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose) | Drug | Placebo |
| PregabalinDosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose) | Drug | Pregabalin |
Primary outcome
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
Time frame: 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).
32 secondary outcomes
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)
Time frame: Week 15 or study discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index
Time frame: Baseline, Week 15 or study discontinuation
Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
Time frame: Week 15 or study discontinuation
Change From Baseline in Sleep Quality Score at Endpoint
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression
Time frame: Baseline, Week 15 or study discontinuation
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
Time frame: Baseline, Week 15 or study discontinuation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26694975Clair 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.
- Derived from this study: PubMed 23062189Ohta 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 35 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (time frame: Baseline, Week 15 or study discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.