The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Anaheim, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Cromwell, Connecticut, United States
...and 49 more locations