To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
Sheehan Disability Scale total score
Average pain item of the BPI and the endpoint of the PGI-Improvement
Reduction of pain severity
Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores
Quality of life
Effect duloxetine on pain is independent of MDD or mood improvement
Assess safety of duloxetine
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Burbank, California, United States
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Sherman Oaks, California, United States
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Walnut Creek, California, United States
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Danbury, Connecticut, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miami, Florida, United States
...and 25 more locations