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

• ClinicalTrials.gov Identifier: NCT00830167
• Recruitment Status: Completed
• First Posted: January 27, 2009
• Results First Posted: June 1, 2012
• Last Update Posted: January 25, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

Brief Summary:

This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: Placebo; Drug: Pregabalin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 498 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: March 2009
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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 ]
   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.
2. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance [ Time Frame: Baseline, Week 15 or study discontinuation ]
   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.
3. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring [ Time Frame: Baseline, Week 15 or study discontinuation ]
   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.
4. 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 ]
   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.
5. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep [ Time Frame: Baseline, Week 15 or study discontinuation ]
   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.
6. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy [ Time Frame: Baseline, Week 15 or study discontinuation ]
   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.
7. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence [ Time Frame: Baseline, Week 15 or study discontinuation ]
   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.
8. Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index [ Time Frame: Baseline, Week 15 or study discontinuation ]
   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.
9. Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint [ Time Frame: Week 15 or study discontinuation ]
   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.
10. Change From Baseline in Sleep Quality Score at Endpoint [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
11. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
12. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
13. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
14. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
15. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
16. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
17. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
18. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
19. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
20. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
21. Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
22. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
23. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
24. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
25. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
26. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
27. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
28. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
29. Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
30. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
31. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.
32. Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint [ Time Frame: Baseline, Week 15 or study discontinuation ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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-shi, Hokkaido, Japan

Pfizer Investigational Site

Sapporo, 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-ku, Tokyo, Japan

Pfizer Investigational Site

Setagaya, 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's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00830167
• Other Study ID Numbers: A0081208
• First Posted: January 27, 2009
• Results First Posted: June 1, 2012
• Last Update Posted: January 25, 2021
• Last Verified: April 2012

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; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs