Clinical trial NCT00282997: A Safety Study Of Pregabalin In Fibromyalgia
Official title: A 12-Week, 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: 2006-01-27
Enrollment: 500
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: To evaluate the safety of pregabalin in patients with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must complete the double-blind study.

Exclusion Criteria:

* Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

Primary outcomes:
measure: To evaluate the safety of pregabalin in patients with fibromyalgia
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
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: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sunrise
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gurnee
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Moline
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Pratt
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Kenner
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Chaska
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Saint Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Morristown
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: West Seneca
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Minot
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Goose Creek
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Milan
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Bedford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Georgetown
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Killeen
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
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: Everett
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
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.