An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
1 other identifier
interventional
428
1 country
93
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2005
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJanuary 22, 2021
July 1, 2006
September 7, 2005
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
There are no secondary outcome measures
Interventions
Eligibility Criteria
You may qualify if:
- Must have received pregabalin/placebo under double-blind conditions.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
Pfizer Investigational Site
Birmingham, Alabama, 35294-3405, United States
Pfizer Investigational Site
Birmingham, Alabama, 35294-6909, United States
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Pfizer Investigational Site
Phoenix, Arizona, 85050, United States
Pfizer Investigational Site
Scottsdale, Arizona, 85254, United States
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Pfizer Investigational Site
Little Rock, Arkansas, 72205-7101, United States
Pfizer Investigational Site
Beverly Hills, California, 90211, United States
Pfizer Investigational Site
Los Alamitos, California, 90720, United States
Pfizer Investigational Site
Newport Beach, California, 92660, United States
Pfizer Investigational Site
Northridge, California, 91324-4625, United States
Pfizer Investigational Site
Pismo Beach, California, 93449, United States
Pfizer Investigational Site
Redondo Beach, California, 90277, United States
Pfizer Investigational Site
Riverside, California, 92506, United States
Pfizer Investigational Site
Walnut Creek, California, 94598, United States
Pfizer Investigational Site
Whittier, California, 90601, United States
Pfizer Investigational Site
Danbury, Connecticut, 06810, United States
Pfizer Investigational Site
New Milford, Connecticut, 06776, United States
Pfizer Investigational Site
Stratford, Connecticut, 06615, United States
Pfizer Investigational Site
Clearwater, Florida, 33761, United States
Pfizer Investigational Site
Miami, Florida, 33173, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410, United States
Pfizer Investigational Site
Seminole, Florida, 33708, United States
Pfizer Investigational Site
St. Petersburg, Florida, 33703, United States
Pfizer Investigational Site
St. Petersburg, Florida, 33709, United States
Pfizer Investigational Site
St. Petersburg, Florida, 33710, United States
Pfizer Investigational Site
Sunrise, Florida, 33351-6637, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33409, United States
Pfizer Investigational Site
Atlanta, Georgia, 30328, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Boise, Idaho, 83704, United States
Pfizer Investigational Site
Chicago, Illinois, 60610, United States
Pfizer Investigational Site
Maywood, Illinois, 60153, United States
Pfizer Investigational Site
Oak Brook, Illinois, 60523, United States
Pfizer Investigational Site
Peoria, Illinois, 61614, United States
Pfizer Investigational Site
Kansas City, Kansas, 66160, United States
Pfizer Investigational Site
Overland Park, Kansas, 66215, United States
Pfizer Investigational Site
Madisonville, Kentucky, 42431, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70114, United States
Pfizer Investigational Site
Newton, Massachusetts, 02462, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49009, United States
Pfizer Investigational Site
Lansing, Michigan, 48917, United States
Pfizer Investigational Site
Kansas City, Missouri, 64114, United States
Pfizer Investigational Site
Lebanon, New Hampshire, 03766, United States
Pfizer Investigational Site
Princeton, New Jersey, 08540, United States
Pfizer Investigational Site
Albany, New York, 12205, United States
Pfizer Investigational Site
New York, New York, 10003, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28210, United States
Pfizer Investigational Site
Wilmington, North Carolina, 28401, United States
Pfizer Investigational Site
Wilmington, North Carolina, 28403, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Columbus, Ohio, 43124, United States
Pfizer Investigational Site
Columbus, Ohio, 43212, United States
Pfizer Investigational Site
Mogadore, Ohio, 44260, United States
Pfizer Investigational Site
Toledo, Ohio, 43623, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73109, United States
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Medford, Oregon, 97504, United States
Pfizer Investigational Site
Portland, Oregon, 97239, United States
Pfizer Investigational Site
Altoona, Pennsylvania, 16602, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904, United States
Pfizer Investigational Site
Mechanicsburg, Pennsylvania, 17055, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19115, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19146, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15218, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15224, United States
Pfizer Investigational Site
Pottstown, Pennsylvania, 19464, United States
Pfizer Investigational Site
West Reading, Pennsylvania, 19611-1124, United States
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610, United States
Pfizer Investigational Site
Anderson, South Carolina, 29621, United States
Pfizer Investigational Site
Charleston, South Carolina, 29406, United States
Pfizer Investigational Site
Greer, South Carolina, 29651, United States
Pfizer Investigational Site
Memphis, Tennessee, 38104, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Lubbock, Texas, 79424, United States
Pfizer Investigational Site
Richardson, Texas, 75080, United States
Pfizer Investigational Site
San Antonio, Texas, 78229-4548, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84107, United States
Pfizer Investigational Site
Woodstock, Vermont, 05091, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23454, United States
Pfizer Investigational Site
Seattle, Washington, 98104, United States
Pfizer Investigational Site
Seattle, Washington, 98122, United States
Pfizer Investigational Site
Yakima, Washington, 98902, United States
Related Publications (1)
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.
PMID: 22503162DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
January 1, 2005
Study Completion
June 1, 2006
Last Updated
January 22, 2021
Record last verified: 2006-07