This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

Condition(s) targeted: Fibromyalgia

Intervention: Pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 12 week open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081100.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Quebec G1V 3M7, Canada; Active, not recruiting

Pfizer Investigational Site, Frederiksberg 2000, Denmark; Active, not recruiting

Pfizer Investigational Site, Svendborg 5700, Denmark; Completed

Pfizer Investigational Site, Paris Cedex 04 75181, France; Recruiting

Pfizer Investigational Site, SAINT PRIEST EN JAREZ 42270, France; Active, not recruiting

Pfizer Investigational Site, Clermont Ferrand Cedex 1 63003, France; Completed

Pfizer Investigational Site, Muenchen 80336, Germany; Recruiting

Pfizer Investigational Site, Berlin 10117, Germany; Recruiting

Pfizer Investigational Site, Berlin 14109, Germany; Completed

Pfizer Investigational Site, Mannheim 68161, Germany; Recruiting

Pfizer Investigational Site, Pisa, Italy; Active, not recruiting

Pfizer Investigational Site, Chieti Scalo 66013, Italy; Recruiting

Pfizer Investigational Site, Benevento 82100, Italy; Recruiting

Pfizer Investigational Site, Bari 79124, Italy; Recruiting

Pfizer Investigational Site, Bologna 40138, Italy; Recruiting

Pfizer Investigational Site, Seoul 133-792, Korea, Republic of; Completed

Pfizer Investigational Site, Seoul 143-914, Korea, Republic of; Completed

Pfizer Investigational Site, Leeuwarden 8934 AD, Netherlands; Recruiting

Pfizer Investigational Site, Alkmaar 1815 JD, Netherlands; Completed

Pfizer Investigational Site, Den Helder 1782 GZ, Netherlands; Completed

Pfizer Investigational Site, Zwolle 8011 JW, Netherlands; Completed

Pfizer Investigational Site, Lisbon 1700-360, Portugal; Active, not recruiting

Pfizer Investigational Site, Molndal 431 37, Sweden; Recruiting

Pfizer Investigational Site, Linkoping 581 85, Sweden; Recruiting

Pfizer Investigational Site, Stockholm SE-112 81, Sweden; Recruiting

Pfizer Investigational Site, Orebro 701 85, Sweden; Recruiting

Pfizer Investigational Site, Zürich 8063, Switzerland; Active, not recruiting

Pfizer Investigational Site, Zurich 8091, Switzerland; Active, not recruiting

Pfizer Investigational Site, Poole BH12 2JB, United Kingdom; Recruiting

Pfizer Investigational Site, London WC1X 8LD, United Kingdom; Recruiting

Pfizer Investigational Site, Kelowna, British Columbia V1Y 2H4, Canada; Active, not recruiting

Pfizer Investigational Site, Lille, Cedex 59037, France; Recruiting

Pfizer Investigational Site, Montpellier, Cedex 5 34295, France; Completed

Pfizer Investigational Site, Manchester, Greater Manchester M6 8HD, United Kingdom; Recruiting

Pfizer Investigational Site, Suwon-si, Kyeongki-do 442-712, Korea, Republic of; Completed

Pfizer Investigational Site, Indore, Madhya Pradesh 452001, India; Recruiting

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1R9, Canada; Active, not recruiting

Pfizer Investigational Site, Bathurst, New Brunswick E2A 4X7, Canada; Completed

Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1B 3E1, Canada; Active, not recruiting

Pfizer Investigational Site, Hawkesbury, Ontario K6A 1A1, Canada; Completed

Pfizer Investigational Site, Toronto, Ontario M3K 2A7, Canada; Completed

Pfizer Investigational Site, Ludhiana, Punjab 141 008, India; Recruiting

Pfizer Investigational Site, Ludhiana, Punjab 141 001, India; Recruiting

Pfizer Investigational Site, Sherbrooke, Quebec J1H 5N4, Canada; Completed

Pfizer Investigational Site, Drummondville, Quebec J2B 7T1, Canada; Completed

Pfizer Investigational Site, Pointe Claire, Quebec H9R 3J1, Canada; Active, not recruiting

Pfizer Investigational Site, Montreal, Quebec H3T 1E2, Canada; Active, not recruiting

Pfizer Investigational Site, Sherbrooke, Quebec J1H 1Z1, Canada; Active, not recruiting

Pfizer Investigational Site, Greenock, Renfrewshire PA16 0XN, United Kingdom; Active, not recruiting

Pfizer Investigational Site, North Shields, Tyne and Wear NE29 8NH, United Kingdom; Recruiting

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226 014, India; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: December 2006
Last updated: December 12, 2007