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Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00424892
First received: January 18, 2007
Last updated: December 4, 2007
Last verified: December 2007
History of Changes
  Purpose

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 Intervention Phase
Fibromyalgia
 Drug: Desvenlafaxine Sustained Release
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 600
Study Completion Date: June 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424892

  Hide Study Locations
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, 60612
Chicago, Illinois, United States, 60611
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
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00424892     History of Changes
Other Study ID Numbers: 3151A4-330
Study First Received: January 18, 2007
Last Updated: December 4, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013