Clinical trial NCT00151528: An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
Official title: A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 428
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 main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.


Eligibility criteria: Inclusion Criteria:

* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
* Must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.

Primary outcomes:
measure: Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
Secondary outcomes:
measure: There are no secondary outcome measures
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Northridge
country: United States
facility: Pfizer Investigational Site
state: California
city: Pismo Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Redondo Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Riverside
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Whittier
country: United States
facility: Pfizer Investigational Site
state: California
city: Danbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Milford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Stratford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Seminole
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sunrise
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Newton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Lansing
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mogadore
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pottstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richardson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Yakima
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.