Clinical trial NCT00346034: This Study is An Open-Label Trial Of Pregabalin In Patients With 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: 2006-06-29
Enrollment: 357
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 A0081100 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 A0081100, and 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 A0081100 which was determined to be related to the study medication by the investigator or the sponsor.

Primary outcomes:
measure: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
timeFrame: Week 4
measure: Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
timeFrame: Week 12 (end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Bathurst
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Drummondville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Frederiksberg
country: Denmark
facility: Pfizer Investigational Site
city: Svendborg
country: Denmark
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
state: Cedex 5
city: Lille
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Clermont Ferrand Cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 04
country: France
facility: Pfizer Investigational Site
city: Saint Priest En Jarez
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Bari
country: Italy
facility: Pfizer Investigational Site
city: Benevento
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Chieti Scalo
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Suwon-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Kyeongki-do
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Den Helder
country: Netherlands
facility: Pfizer Investigational Site
city: Leeuwarden
country: Netherlands
facility: Pfizer Investigational Site
city: Zwolle
country: Netherlands
facility: Pfizer Investigational Site
city: Lisbon
country: Portugal
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Molndal
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: Zürich
country: Switzerland
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
state: Greater Manchester
city: Greenock
country: United Kingdom
facility: Pfizer Investigational Site
state: Renfrewshire
city: North Shields
country: United Kingdom
facility: Pfizer Investigational Site
state: Tyne And Wear
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Poole
country: United Kingdom
facility: Pfizer Investigational Site
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.