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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Experimental: Pregabalin	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (Estimate): January 27, 2009

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081208