Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome

December 4, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Phoenix, Arizona, United States, 85016
    • 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
    • Colorado
      • Denver, Colorado, United States, 80218
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
    • 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
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Decatur, Georgia, United States, 30033
      • Smyrna, Georgia, United States, 30080
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40536
    • Maryland
      • Rockville, Maryland, United States, 20852
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Newton, Massachusetts, United States, 02462
    • Michigan
      • Lansing, Michigan, United States, 48910
    • Missouri
      • Kansas City, Missouri, United States, 64114
      • St. Louis, Missouri, United States, 63117
    • Nevada
      • Las Vegas, Nevada, United States, 89106
    • New Jersey
      • Clementon, New Jersey, United States, 08021
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Dayton, Ohio, United States, 45408
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74104
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • Harleysville, Pennsylvania, United States, 19438
      • Philadelphia, Pennsylvania, United States, 19152
      • Philadelphia, Pennsylvania, United States, 19149
      • Sellersville, Pennsylvania, United States, 18960
      • West Reading, Pennsylvania, United States, 19611
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Charleston, South Carolina, United States, 29407
      • Summerville, South Carolina, United States, 29485
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Chattanooga, Tennessee, United States, 37404
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Austin, Texas, United States, 78756
      • Dallas, Texas, United States, 75231
      • San Antonio, Texas, United States, 78205
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 18, 2007

First Submitted That Met QC Criteria

January 18, 2007

First Posted (Estimate)

January 22, 2007

Study Record Updates

Last Update Posted (Estimate)

December 6, 2007

Last Update Submitted That Met QC Criteria

December 4, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3151A4-330

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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