Clinical trial NCT00424892: Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome
Official title: A 6-Month Open-Label Extension Study of the Long-Term Safety of DVS SR in Outpatients With Fibromyalgia Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fibromyalgia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.

Detailed description: Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.

Eligibility criteria: Inclusion Criteria:

* Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.
* Women of childbearing potential must have a negative serum pregnancy test result at study start.

Exclusion criteria:

* Presence of any new/and or clinically important medical condition that might compromise patient's safety.
* Use of prohibited treatment.
* Meets any of the exclusion criteria listed for study 3151A4-327.

Primary outcomes:
measure: The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.
Secondary outcomes:
measure: Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.
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: