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NCT00301431 Clinical Trial

Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00301431
Other study ID # 3151A4-327
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received March 8, 2006
Last updated December 3, 2007
Start date August 2006
Est. completion date June 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 1050
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DVS-233

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
Secondary Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
See also
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