Clinical trial NCT00830167: Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Official title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
timeFrame: Baseline, Week 15 or study discontinuation
Secondary outcomes:
measure: 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)
timeFrame: Week 15 or study discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index
timeFrame: Baseline, Week 15 or study discontinuation
measure: Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
timeFrame: Week 15 or study discontinuation
measure: Change From Baseline in Sleep Quality Score at Endpoint
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression
timeFrame: Baseline, Week 15 or study discontinuation
measure: Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
timeFrame: Baseline, Week 15 or study discontinuation
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Ichihara-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Yotukaidou
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Matuyama-si
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Iiduka
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Takasaki
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Sapporo-shi
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyougo
city: Mito
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Morioka
country: Japan
facility: Pfizer Investigational Site
state: Iwate
city: Sagamihara-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Koushi
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto
city: Tsu
country: Japan
facility: Pfizer Investigational Site
state: Mie
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Hiki-gun
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Saitama-city
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Saitama-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Aoi-ku
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chuou-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Itabashi-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toyama-shi
country: Japan
facility: Pfizer Investigational Site
state: Toyama
city: Nagano
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Tokushima
country: Japan
facility: Pfizer Investigational Site
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.