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A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: Desvenlafaxine Sustained Release (DVS SR) (Drug); Lyrica® (Pregabalin) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer


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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline on the Numeric Rating Scale (NRS)

Secondary outcome: Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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


- Treatment with other drugs for fibromyalgia with 14 days of study start or during the


Locations and Contacts

Huntsville, Alabama 35801, United States

Roseville, California 95661, United States

San Diego, California 92108, United States

San Diego, California 92128, United States

Santa Ana, California 92705, United States

Walnut Creek, California 94598, United States

Jacksonville, Florida 32216, United States

Tampa, Florida 33606, United States

Decatur, Georgia 30033, United States

Evansville, Indiana 47714, United States

Indianapolis, Indiana 46260, United States

Lexington, Kentucky 40509, United States

Rockville, Maryland 20852, United States

Lansing, Michigan 48910, United States

Raleigh, North Carolina 27612, United States

Cincinnati, Ohio 45219, United States

Dayton, Ohio 45408, United States

Duncansville, Pennsylvania 16635, United States

Philadelphia, Pennsylvania 19152, United States

Chattanooga, Tennessee 37404, United States

Chattanooga, Tennessee 37421, United States

Knoxville, Tennessee 37920, United States

Austin, Texas 78756, United States

Dallas, Texas 75231, United States

San Antonio, Texas 78205, United States

Salt Lake City, Utah 84102, United States

Middleton, Wisconsin 53562, United States

Additional Information

Starting date: June 2008
Last updated: February 20, 2013

Page last updated: August 23, 2015

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