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Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00301431
First Posted: March 10, 2006
Last Update Posted: December 5, 2007
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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.

Condition Intervention Phase
Fibromyalgia Drug: DVS-233 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change

Estimated Enrollment: 1050
Study Start Date: August 2006
Study Completion Date: June 2007
  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00301431


  Show 59 Study Locations
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

ClinicalTrials.gov Identifier: NCT00301431     History of Changes
Other Study ID Numbers: 3151A4-327
First Submitted: March 8, 2006
First Posted: March 10, 2006
Last Update Posted: December 5, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Fibromyalgia
Adults
Outpatients
Adult
Double-Blind Method

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases