Fibromyalgia
Conditions
Brief summary
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.
Detailed description
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.
Interventions
DRUGDesvenlafaxine Sustained Release
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure. | — |
Countries
United States
Outcome results
None listed