A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
1 other identifier
interventional
125
1 country
27
Brief Summary
The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
27 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
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
February 23, 2010
CompletedFebruary 25, 2013
February 1, 2013
7 months
June 11, 2008
January 29, 2010
February 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline on the Numeric Rating Scale (NRS)
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Baseline and 8 weeks
Secondary Outcomes (1)
Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
Baseline and 8 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORIn the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
DVS SR
EXPERIMENTALIn the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
Pregabalin
ACTIVE COMPARATORIn the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
Interventions
Eligibility Criteria
You may qualify if:
- \- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria
You may not qualify if:
- Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
- Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
- 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 (27)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Diego, California, 92128, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Lexington, Kentucky, 40509, United States
Unknown Facility
Rockville, Maryland, 20852, United States
Unknown Facility
Lansing, Michigan, 48910, United States
Unknown Facility
Raleigh, North Carolina, 27612, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Dayton, Ohio, 45408, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Philadelphia, Pennsylvania, 19152, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Chattanooga, Tennessee, 37421, United States
Unknown Facility
Knoxville, Tennessee, 37920, 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
Salt Lake City, Utah, 84102, United States
Unknown Facility
Middleton, Wisconsin, 53562, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
February 25, 2013
Results First Posted
February 23, 2010
Record last verified: 2013-02