Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830167
• Other study ID #: A0081208
• Status: Completed
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Placebo
Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
• Pregabalin
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)

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Aoi-ku	Shizuoka
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Chuou-Ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Hiki-gun	Saitama
Japan	Pfizer Investigational Site	Ichihara-shi	Chiba
Japan	Pfizer Investigational Site	Iiduka	Fukuoka
Japan	Pfizer Investigational Site	Itabashi-Ku	Tokyo
Japan	Pfizer Investigational Site	Kitakyusyu	Fukuoka
Japan	Pfizer Investigational Site	Kobe	Hyogo
Japan	Pfizer Investigational Site	Kobe	Hyougo
Japan	Pfizer Investigational Site	Koushi	Kumamoto
Japan	Pfizer Investigational Site	Matuyama-si	Ehime
Japan	Pfizer Investigational Site	Mito	Ibaraki
Japan	Pfizer Investigational Site	Morioka	Iwate
Japan	Pfizer Investigational Site	Nagano
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Oita
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Sagamihara-shi	Kanagawa
Japan	Pfizer Investigational Site	Saitama-city	Saitama
Japan	Pfizer Investigational Site	Saitama-shi	Saitama
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo-shi	Hokkaido
Japan	Pfizer Investigational Site	Sendai	Miyagi
Japan	Pfizer Investigational Site	Setagaya	Tokyo
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Japan	Pfizer Investigational Site	Shimotsuga-gun	Tochigi
Japan	Pfizer Investigational Site	Shinagawa-Ku	Tokyo
Japan	Pfizer Investigational Site	Takasaki	Gunma
Japan	Pfizer Investigational Site	Tokushima
Japan	Pfizer Investigational Site	Toyama-shi	Toyama
Japan	Pfizer Investigational Site	Tsu	Mie
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Yokohama
Japan	Pfizer Investigational Site	Yotukaidou	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, Week 15 or study discontinuation
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.	Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation
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.	Baseline, Week 15 or study discontinuation

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