Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

Phase 2

Terminated

• Conditions: Fibromyalgia

• Registration Number: NCT00301431
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-10
• Study Start: 2006-08
• Study Completion: 2007-06
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1050

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change