A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
Information source: Wyeth
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: Desvenlafaxine Sustained Release (DVS SR) (Drug); Lyrica® (Pregabalin) (Drug); Placebo (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
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.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: Numeric rating scale (NRS) for pain
Secondary outcome: Fibromyalgia impact questionnaire, Patient global impression
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria
Exclusion Criteria:
- 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
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Huntsville, Alabama 35801, United States; Recruiting
Walnut Creek, California 94598, United States; Recruiting
San Diego, California 92108, United States; Recruiting
San Diego, California 92128, United States; Terminated
Santa Ana, California 92705, United States; Recruiting
Roseville, California 95661, United States; Recruiting
Jacksonville, Florida 32216, United States; Recruiting
Tampa, Florida 33606, United States; Recruiting
Decatur, Georgia 30033, United States; Recruiting
Evansville, Indiana 47714, United States; Recruiting
Indianapolis, Indiana 46260, United States; Recruiting
Lexington, Kentucky 40509, United States; Recruiting
Rockville, Maryland 20852, United States; Recruiting
Lansing, Michigan 48910, United States; Recruiting
Raleigh, North Carolina 27612, United States; Recruiting
Cincinnati, Ohio 45219, United States; Recruiting
Dayton, Ohio 45408, United States; Recruiting
Duncansville, Pennsylvania 16635, United States; Recruiting
Philadelphia, Pennsylvania 19152, United States; Recruiting
Chattanooga, Tennessee 37404, United States; Recruiting
Chattanooga, Tennessee 37421, United States; Terminated
Knoxville, Tennessee 37920, United States; Recruiting
San Antonio, Texas 78205, United States; Recruiting
Dallas, Texas 75231, United States; Recruiting
Austin, Texas 78756, United States; Recruiting
Salt Lake City, Utah 84102, United States; Recruiting
Middleton, Wisconsin 53562, United States; Recruiting
Additional Information
Starting date: June 2008
Ending date: November 2009
Last updated: November 3, 2008
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