Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00830167
First received: January 26, 2009
Last updated: April 30, 2012
Last verified: April 2012
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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
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 May 23, 2013