Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00424892
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : December 6, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Desvenlafaxine Sustained Release Phase 2 Phase 3

Detailed Description:
Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Primary Outcome Measures :
  1. The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.

Secondary Outcome Measures :
  1. Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
  • Women of childbearing potential must have a negative serum pregnancy test result at study start.

Exclusion criteria:

  • Presence of any new/and or clinically important medical condition that might compromise patient's safety.
  • Use of prohibited treatment.
  • Meets any of the exclusion criteria listed for study 3151A4-327.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424892

  Hide Study Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85016
United States, California
Anaheim, California, United States, 92801
Sacramento, California, United States, 95825
San Diego, California, United States, 92108
Santa Ana, California, United States, 92705
Walnut Creek, California, United States, 94598
United States, Colorado
Denver, Colorado, United States, 80218
United States, Connecticut
Cromwell, Connecticut, United States, 06416
United States, Florida
Brooksville, Florida, United States, 34613
Deland, Florida, United States, 32720
Delray Beach, Florida, United States, 33484
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33143
Palm Beach Gardens, Florida, United States, 33418
Pembroke Pines, Florida, United States, 33026
St. Petersburg, Florida, United States, 33709
Sunrise, Florida, United States, 33351
Tamarac, Florida, United States, 33321
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30342
Decatur, Georgia, United States, 30033
Smyrna, Georgia, United States, 30080
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Lexington, Kentucky, United States, 40509
Lexington, Kentucky, United States, 40536
United States, Maryland
Rockville, Maryland, United States, 20852
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Newton, Massachusetts, United States, 02462
United States, Michigan
Lansing, Michigan, United States, 48910
United States, Missouri
Kansas City, Missouri, United States, 64114
St. Louis, Missouri, United States, 63117
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Clementon, New Jersey, United States, 08021
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45219
Dayton, Ohio, United States, 45408
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73112
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Harleysville, Pennsylvania, United States, 19438
Philadelphia, Pennsylvania, United States, 19149
Philadelphia, Pennsylvania, United States, 19152
Sellersville, Pennsylvania, United States, 18960
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Charleston, South Carolina, United States, 29407
Summerville, South Carolina, United States, 29485
United States, Tennessee
Bristol, Tennessee, United States, 37620
Chattanooga, Tennessee, United States, 37404
Memphis, Tennessee, United States, 38119
United States, Texas
Austin, Texas, United States, 78756
Dallas, Texas, United States, 75231
San Antonio, Texas, United States, 78205
United States, Wisconsin
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00424892     History of Changes
Other Study ID Numbers: 3151A4-330
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs