Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome
Status and phase
Completed
Phase 3
Phase 2
Conditions
Fibromyalgia
Treatments
Drug: Desvenlafaxine Sustained Release
Details and patient eligibility
About
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.
Full description
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
- Women of childbearing potential must have a negative serum pregnancy test result at study start.
Exclusion criteria
- Presence of any new/and or clinically important medical condition that might compromise patient's safety.
- Use of prohibited treatment.
- Meets any of the exclusion criteria listed for study 3151A4-327.
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
Trial contacts and locations
59
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Data sourced from clinicaltrials.gov
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