This is a study to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,129
10 mg oral tablet once a day dosing
0 mg oral tablet once a day dosing
4 mg oral tablet once a day dosing
Change from baseline in the endpoint mean pain score
Time frame: 14 weeks
Fibromyalgia Impact Questionnaire
Time frame: 14 weeks
Change from baseline in the endpoint mean sleep interference score
Time frame: 14 weeks
Patient Global Impression of Change
Time frame: 14 weeks
Multidimensional Assessment of Fatigue
Time frame: 14 weeks
Hospital Anxiety and Depression Scale
Time frame: 14 weeks
Short Form 36
Time frame: 14 weeks
Sheehan Disability Score
Time frame: 14 weeks
Pain Visual Analogue Scale
Time frame: 14 weeks
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8 mg oral tablet once a day dosing
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Tallassee, Alabama, United States
Pfizer Investigational Site
Chandler, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Carmichael, California, United States
Pfizer Investigational Site
Elk Grove, California, United States
Pfizer Investigational Site
Fullerton, California, United States
Pfizer Investigational Site
Lafayette, California, United States
...and 135 more locations