Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome
A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
1 other identifier
interventional
600
1 country
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 6, 2007
December 1, 2007
January 18, 2007
December 4, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Presence of any new/and or clinically important medical condition that might compromise patient's safety.
- Use of prohibited treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Sacramento, California, 95825, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Cromwell, Connecticut, 06416, United States
Unknown Facility
Brooksville, Florida, 34613, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Delray Beach, Florida, 33484, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
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Miami, Florida, 33143, United States
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Palm Beach Gardens, Florida, 33418, United States
Unknown Facility
Pembroke Pines, Florida, 33026, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
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Sunrise, Florida, 33351, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33606, United States
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Atlanta, Georgia, 30342, United States
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Decatur, Georgia, 30033, United States
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Smyrna, Georgia, 30080, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Indianapolis, Indiana, 46202, United States
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Lexington, Kentucky, 40509, United States
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Lexington, Kentucky, 40536, United States
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Rockville, Maryland, 20852, United States
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Boston, Massachusetts, 02115, United States
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Newton, Massachusetts, 02462, United States
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Lansing, Michigan, 48910, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63117, United States
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Las Vegas, Nevada, 89106, United States
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Clementon, New Jersey, 08021, United States
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Raleigh, North Carolina, 27612, United States
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Cincinnati, Ohio, 45219, United States
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Dayton, Ohio, 45408, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73112, United States
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Tulsa, Oklahoma, 74104, United States
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Duncansville, Pennsylvania, 16635, United States
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Harleysville, Pennsylvania, 19438, United States
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Philadelphia, Pennsylvania, 19149, United States
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Philadelphia, Pennsylvania, 19152, United States
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Sellersville, Pennsylvania, 18960, United States
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West Reading, Pennsylvania, 19611, United States
Unknown Facility
Warwick, Rhode Island, 02886, United States
Unknown Facility
Charleston, South Carolina, 29407, United States
Unknown Facility
Summerville, South Carolina, 29485, United States
Unknown Facility
Bristol, Tennessee, 37620, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Austin, Texas, 78756, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
San Antonio, Texas, 78205, United States
Unknown Facility
Middleton, Wisconsin, 53562, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 18, 2007
First Posted
January 22, 2007
Study Completion
June 1, 2007
Last Updated
December 6, 2007
Record last verified: 2007-12