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

January 26, 2009
April 30, 2012
March 2009
May 2011   (final data collection date for 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 ] [ 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).
Numerical rating scale for pain [ Time Frame: 15 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00830167 on ClinicalTrials.gov Archive Site
  • 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.
  • Patient Global Impression of Change (PGIC) [ Time Frame: 15 ] [ Designated as safety issue: No ]
  • Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) [ Time Frame: 15 ] [ Designated as safety issue: No ]
  • Quality of Sleep Score from the Daily Sleep Diary [ Time Frame: 15 ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 15 ] [ Designated as safety issue: No ]
  • Short-Form 36 Health Survey (SF-36) [ Time Frame: 15 ] [ Designated as safety issue: No ]
  • Pain Visual Analog Scale (Pain VAS) [ Time Frame: 15 ] [ Designated as safety issue: No ]
  • Assessment of Safety [ Time Frame: 16 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Placebo
    Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
  • 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)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
498
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00830167
A0081208
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP