Clinical trial NCT00301431: Study Evaluating the Efficacy of DVS-233 in Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Adults
Outpatients
Adult
Double-Blind Method
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-03-10
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary outcome will be the change in the daily pain score from baseline to study day 105 of therapy.
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire and the Patient Global Impression of Change
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Cromwell
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Deland
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Rockville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Newton
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Clementon
country: United States
state: New Jersey
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Summerville
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Middleton
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: