Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adaptive Design, Efficacy and Tolerability Study of 4 Fixed Doses of DVS-233 in Adult Outpatients With Fibromyalgia Syndrome

The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1050

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, 33613
      • Deland, Florida, United States, 32720
      • Delray Beach, Florida, United States, 33484
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33173
      • Palm Beach Gardens, Florida, United States, 33418
      • Pembroke Pines, Florida, United States, 33026
      • St. Petersburg, Florida, United States, 33709
      • Sunrise, Florida, United States, 33351-6637
      • 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, 40536-0284
    • 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:

  • Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

  • Other painful conditions that may make results difficult to interpret.
  • Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.

Secondary Outcome Measures

Outcome Measure
Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change

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 Start

August 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 8, 2006

First Submitted That Met QC Criteria

March 9, 2006

First Posted (Estimate)

March 10, 2006

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3151A4-327

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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