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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

Page last updated: November 03, 2008

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