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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00830167
First received: January 26, 2009
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Placebo
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin(CI-1008)In The Treatment Of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
    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.


Enrollment: 498
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830167

Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Ichihara-shi, Chiba, Japan
Pfizer Investigational Site
Yotukaidou, Chiba, Japan
Pfizer Investigational Site
Matuyama-si, Ehime, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Iiduka, Fukuoka, Japan
Pfizer Investigational Site
Kitakyusyu, Fukuoka, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Sapporo-shi, Hokkaido, Japan
Pfizer Investigational Site
Kobe, Hyogo, Japan
Pfizer Investigational Site
Kobe, Hyougo, Japan
Pfizer Investigational Site
Mito, Ibaraki, Japan
Pfizer Investigational Site
Morioka, Iwate, Japan
Pfizer Investigational Site
Sagamihara-shi, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Koushi, Kumamoto, Japan
Pfizer Investigational Site
Tsu, Mie, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Hiki-gun, Saitama, Japan
Pfizer Investigational Site
Saitama-city, Saitama, Japan
Pfizer Investigational Site
Saitama-shi, Saitama, Japan
Pfizer Investigational Site
Aoi-ku, Shizuoka, Japan
Pfizer Investigational Site
Shimotsuga-gun, Tochigi, 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
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-shi, Toyama, Japan
Pfizer Investigational Site
Nagano, Japan
Pfizer Investigational Site
Oita, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Tokushima, Japan
Pfizer Investigational Site
Yokohama, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00830167     History of Changes
Other Study ID Numbers: A0081208
Study First Received: January 26, 2009
Results First Received: April 30, 2012
Last Updated: April 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 28, 2014