The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
751
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Paradise Valley, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Endpoint mean pain score derived from the subject's daily pain diary
Time frame: Endpoint
Patient Global Assessment (Patient Global Impression of Change) at Termination Visit
Time frame: Weeks 5 and 13
Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit
Time frame: Baseline and Weeks 5, 9, and 13
Change from baseline in FIQ scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Change from baseline in SDS scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Quality of Sleep Score from the Daily Sleep Diary
Time frame: Daily
Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13
Time frame: Baseline and Weeks 5, 9, and 13
Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13
Time frame: Baseline and Week 13
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13
Time frame: Screening, baseline, and Weeks 5, 9, and 13
Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13
Time frame: Baseline and Weeks 9 and 13
Adverse events
Time frame: Weeks 1, 2, 5, 9, 13, and at follow-up
Physical examination, including vital signs and weight
Time frame: Baseline and Week 5 (vital signs only) and 13
Neurological examination
Time frame: Screening and Week 13
Electrocardiogram
Time frame: Screening and Week 13
Laboratory tests, including chemistry and hematology
Time frame: Baseline and Weeks 5, 13, and at follow-up
Urinalysis
Time frame: Baseline and Weeks 13 and at follow-up
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Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Hot Springs, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Long Beach, California, United States
...and 92 more locations