NCT00301431
Terminated
Phase 2
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
Wyeth is now a wholly owned subsidiary of Pfizer0 sites1,050 target enrollmentAugust 2006
ConditionsFibromyalgia
DrugsDVS-233
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 1050
- Primary Endpoint
- The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
- Status
- Terminated
- Last Updated
- 18 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
Secondary Outcomes
- Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
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