Study Evaluating the Efficacy of DVS-233 in Fibromyalgia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome
1 other identifier
interventional
1,050
1 country
59
Brief Summary
The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of 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
Started Aug 2006
Shorter than P25 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
March 8, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 5, 2007
December 1, 2007
March 8, 2006
December 3, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
Secondary Outcomes (1)
Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
Interventions
Eligibility Criteria
You may qualify if:
- Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria
You may not qualify if:
- Other painful conditions that may make results difficult to interpret.
- Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.
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, 33613, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Delray Beach, Florida, 33484, United States
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Jacksonville, Florida, 32216, United States
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Miami, Florida, 33173, 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
Unknown Facility
Sunrise, Florida, 33351-6637, United States
Unknown Facility
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, 40536-0284, 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
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Warwick, Rhode Island, 02886, United States
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Charleston, South Carolina, 29407, United States
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Summerville, South Carolina, 29485, United States
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Bristol, Tennessee, 37620, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
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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
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 8, 2006
First Posted
March 10, 2006
Study Start
August 1, 2006
Study Completion
June 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12