An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00151528
First received: September 7, 2005
Last updated: March 7, 2008
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Drug: Pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • There are no secondary outcome measures [ Designated as safety issue: No ]

Estimated Enrollment: 428
Study Start Date: January 2005
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151528

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-3405
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-6909
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85050
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85254
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205-7101
United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
Pfizer Investigational Site
Los Alamitos, California, United States, 90720
Pfizer Investigational Site
Newport Beach, California, United States, 92660
Pfizer Investigational Site
Northridge, California, United States, 91324-4625
Pfizer Investigational Site
Pismo Beach, California, United States, 93449
Pfizer Investigational Site
Redondo Beach, California, United States, 90277
Pfizer Investigational Site
Riverside, California, United States, 92506
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
Pfizer Investigational Site
Whittier, California, United States, 90601
United States, Connecticut
Pfizer Investigational Site
Danbury, Connecticut, United States, 06810
Pfizer Investigational Site
New Milford, Connecticut, United States, 06776
Pfizer Investigational Site
Stratford, Connecticut, United States, 06615
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33761
Pfizer Investigational Site
Miami, Florida, United States, 33173
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States, 33410
Pfizer Investigational Site
Seminole, Florida, United States, 33708
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33709
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33710
Pfizer Investigational Site
St. Petersburg, Florida, United States, 33703
Pfizer Investigational Site
Sunrise, Florida, United States, 33351-6637
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83704
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
Pfizer Investigational Site
Maywood, Illinois, United States, 60153
Pfizer Investigational Site
Oak Brook, Illinois, United States, 60523
Pfizer Investigational Site
Peoria, Illinois, United States, 61614
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160
Pfizer Investigational Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70114
United States, Massachusetts
Pfizer Investigational Site
Newton, Massachusetts, United States, 02462
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49009
Pfizer Investigational Site
Lansing, Michigan, United States, 48917
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03766
United States, New Jersey
Pfizer Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12205
Pfizer Investigational Site
New York, New York, United States, 10003
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Wilmington, North Carolina, United States, 28401
Pfizer Investigational Site
Wilmington, North Carolina, United States, 28403
Pfizer Investigational Site
Winston Salem, North Carolina, United States, 27103
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Columbus, Ohio, United States, 43212
Pfizer Investigational Site
Columbus, Ohio, United States, 43124
Pfizer Investigational Site
Mogadore, Ohio, United States, 44260
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
Pfizer Investigational Site
Medford, Oregon, United States, 97504
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16602
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Pfizer Investigational Site
Johnstown, Pennsylvania, United States, 15904
Pfizer Investigational Site
Mechanicsburg, Pennsylvania, United States, 17055
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19115
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19146
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15218
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
Pfizer Investigational Site
Pottstown, Pennsylvania, United States, 19464
Pfizer Investigational Site
West Reading, Pennsylvania, United States, 19611-1124
Pfizer Investigational Site
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Pfizer Investigational Site
Anderson, South Carolina, United States, 29621
Pfizer Investigational Site
Charleston, South Carolina, United States, 29406
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site
Memphis, Tennessee, United States, 38104
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Lubbock, Texas, United States, 79424
Pfizer Investigational Site
Richardson, Texas, United States, 75080
Pfizer Investigational Site
San Antonio, Texas, United States, 78229-4548
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Vermont
Pfizer Investigational Site
Woodstock, Vermont, United States, 05091
United States, Virginia
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Pfizer Investigational Site
Seattle, Washington, United States, 98122
Pfizer Investigational Site
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00151528     History of Changes
Other Study ID Numbers: A0081057
Study First Received: September 7, 2005
Last Updated: March 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 23, 2014