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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
March 8, 2006
March 10, 2006
December 5, 2007
August 2006
Not Provided
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
Same as current
Complete list of historical versions of study NCT00301431 on ClinicalTrials.gov Archive Site
Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
Same as current
Not Provided
Not Provided
 
Study Evaluating the Efficacy of DVS-233 in Fibromyalgia
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Fibromyalgia
Drug: DVS-233
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1050
June 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00301431
3151A4-327
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP