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An Open-Label Trial of Pregabalin in Patients with Fibromyalgia - Article


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Clinical Trial: An Open-Label Trial of Pregabalin in Patients with Fibromyalgia

This study is currently recruiting patients.
Verified by Pfizer September 2005

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00151528

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 III

MedlinePlus related topics:  Fibromyalgia

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title: A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients with Fibromyalgia

Further Study Details: 
Primary Outcomes: 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.
Expected Total Enrollment:  428

Study start: January 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00151528

Pfizer CT.gov Call Center      1-800-718-1021 

Alabama
      Pfizer Investigational Site, Huntsville,  Alabama,  35801,  United States; Recruiting

      Pfizer Investigational Site, Birmingham,  Alabama,  35294,  United States; No longer recruiting

Arizona
      Pfizer Investigational Site, Phoenix,  Arizona,  85032,  United States; Recruiting

      Pfizer Investigational Site, Scottsdale,  Arizona,  85254,  United States; Recruiting

      Pfizer Investigational Site, Phoenix,  Arizona,  85023,  United States; Recruiting

Arkansas
      Pfizer Investigational Site, Hot Springs,  Arkansas,  71913,  United States; Recruiting

      Pfizer Investigational Site, Little Rock,  Arkansas,  72205-7101,  United States; Recruiting

California
      Pfizer Investigational Site, Whittier,  California,  90601,  United States; Recruiting

      Pfizer Investigational Site, Walnut Creek,  California,  94598,  United States; Recruiting

      Pfizer Investigational Site, Redondo Beach,  California,  90277,  United States; Recruiting

      Pfizer Investigational Site, Newport Beach,  California,  92660,  United States; Recruiting

      Pfizer Investigational Site, Riverside,  California,  92506,  United States; Recruiting

      Pfizer Investigational Site, Los Alamitos,  California,  90720,  United States; Recruiting

      Pfizer Investigational Site, Northridge,  California,  91324-4625,  United States; Recruiting

      Pfizer Investigational Site, Pismo Beach,  California,  93449,  United States; Recruiting

      Pfizer Investigational Site, Beverly Hills,  California,  90211,  United States; Recruiting

Connecticut
      Pfizer Investigational Site, Danbury,  Connecticut,  06810,  United States; Recruiting

      Pfizer Investigational Site, New Milford,  Connecticut,  06776,  United States; Recruiting

      Pfizer Investigational Site, Stratford,  Connecticut,  06615,  United States; Recruiting

Florida
      Pfizer Investigational Site, Miami,  Florida,  33173,  United States; Recruiting

      Pfizer Investigational Site, Palm Beach Gardens,  Florida,  33410,  United States; Recruiting

      Pfizer Investigational Site, Clearwater,  Florida,  33761,  United States; Recruiting

      Pfizer Investigational Site, Plantation,  Florida,  33324,  United States; Recruiting

      Pfizer Investigational Site, Sunrise,  Florida,  33351-6637,  United States; Recruiting

      Pfizer Investigational Site, Ocala,  Florida,  34474,  United States; Recruiting

      Pfizer Investigational Site, St. Petersburg,  Florida,  33709,  United States; Recruiting

      Pfizer Investigational Site, St. Petersburg,  Florida,  33703,  United States; Recruiting

      Pfizer Investigational Site, West Palm Beach,  Florida,  33409,  United States; Recruiting

Georgia
      Pfizer Investigational Site, Atlanta,  Georgia,  30328,  United States; Recruiting

      Pfizer Investigational Site, Decatur,  Georgia,  30033,  United States; No longer recruiting

Idaho
      Pfizer Investigational Site, Boise,  Idaho,  83704,  United States; Recruiting

Illinois
      Pfizer Investigational Site, Oak Brook,  Illinois,  60523,  United States; Recruiting

      Pfizer Investigational Site, Chicago,  Illinois,  60610,  United States; No longer recruiting

      Pfizer Investigational Site, Peoria,  Illinois,  61614,  United States; Recruiting

      Pfizer Investigational Site, Maywood,  Illinois,  60153,  United States; No longer recruiting

Kansas
      Pfizer Investigational Site, Overland Park,  Kansas,  66215,  United States; No longer recruiting

      Pfizer Investigational Site, Kansas City,  Kansas,  66160,  United States; Recruiting

Kentucky
      Pfizer Investigational Site, Madisonville,  Kentucky,  42431,  United States; Recruiting

Louisiana
      Pfizer Investigational Site, New Orleans,  Louisiana,  70114,  United States; Recruiting

Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21215,  United States; No longer recruiting

Massachusetts
      Pfizer Investigational Site, Newton,  Massachusetts,  02462,  United States; No longer recruiting

Michigan
      Pfizer Investigational Site, Kalamazoo,  Michigan,  49009,  United States; Recruiting

      Pfizer Investigational Site, Lansing,  Michigan,  48917,  United States; Recruiting

Missouri
      Pfizer Investigational Site, Kansas City,  Missouri,  64114,  United States; Recruiting

New Hampshire
      Pfizer Investigational Site, Lebanon,  New Hampshire,  03766,  United States; Recruiting

New Jersey
      Pfizer Investigational Site, Princeton,  New Jersey,  08540,  United States; Recruiting

New York
      Pfizer Investigational Site, Rochester,  New York,  14618,  United States; Recruiting

      Pfizer Investigational Site, Albany,  New York,  12205,  United States; Recruiting

      Pfizer Investigational Site, New York,  New York,  10003,  United States; Recruiting

North Carolina
      Pfizer Investigational Site, Charlotte,  North Carolina,  28210,  United States; Recruiting

      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting

      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting

      Pfizer Investigational Site, Wilmington,  North Carolina,  28401,  United States; Recruiting

      Pfizer Investigational Site, Wilmington,  North Carolina,  28403,  United States; Recruiting

Ohio
      Pfizer Investigational Site, Toledo,  Ohio,  43623,  United States; Recruiting

      Pfizer Investigational Site, Mogadore,  Ohio,  44260,  United States; Recruiting

      Pfizer Investigational Site, Cincinnati,  Ohio,  45267-0559,  United States; Recruiting

      Pfizer Investigational Site, Columbus,  Ohio,  43124,  United States; No longer recruiting

      Pfizer Investigational Site, Columbus,  Ohio,  43212,  United States; Recruiting

Oklahoma
      Pfizer Investigational Site, Oklahoma City,  Oklahoma,  73109,  United States; No longer recruiting

Oregon
      Pfizer Investigational Site, Medford,  Oregon,  97504,  United States; Recruiting

      Pfizer Investigational Site, Eugene,  Oregon,  97401,  United States; Recruiting

      Pfizer Investigational Site, Portland,  Oregon,  97201,  United States; Recruiting

      Pfizer Investigational Site, Portland,  Oregon,  97239,  United States; Recruiting

Pennsylvania
      Pfizer Investigational Site, West Reading,  Pennsylvania,  19611-1124,  United States; Recruiting

      Pfizer Investigational Site, Pottstown,  Pennsylvania,  19464,  United States; Recruiting

      Pfizer Investigational Site, Wyomissing,  Pennsylvania,  19610,  United States; Recruiting

      Pfizer Investigational Site, Duncansville,  Pennsylvania,  16635,  United States; Recruiting

      Pfizer Investigational Site, Johnstown,  Pennsylvania,  15904,  United States; Recruiting

      Pfizer Investigational Site, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting

      Pfizer Investigational Site, Pittsburgh,  Pennsylvania,  15218,  United States; Recruiting

      Pfizer Investigational Site, Pittsburgh,  Pennsylvania,  15224,  United States; No longer recruiting

      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19115,  United States; Recruiting

      Pfizer Investigational Site, Altoona,  Pennsylvania,  16601,  United States; Recruiting

      Pfizer Investigational Site, Altoona,  Pennsylvania,  16602,  United States; Recruiting

      Pfizer Investigational Site, Mechanicsburg,  Pennsylvania,  17055,  United States; Recruiting

      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19146,  United States; Recruiting

South Carolina
      Pfizer Investigational Site, Anderson,  South Carolina,  29621,  United States; Recruiting

      Pfizer Investigational Site, Greer,  South Carolina,  29651,  United States; Recruiting

      Pfizer Investigational Site, Charleston,  South Carolina,  29406,  United States; Recruiting

Tennessee
      Pfizer Investigational Site, Memphis,  Tennessee,  38119,  United States; Recruiting

      Pfizer Investigational Site, Memphis,  Tennessee,  38104,  United States; Recruiting

      Pfizer Investigational Site, Nashville,  Tennessee,  37203,  United States; Recruiting

Texas
      Pfizer Investigational Site, San Antonio,  Texas,  78229-3900,  United States; Recruiting

      Pfizer Investigational Site, Austin,  Texas,  78705,  United States; Recruiting

      Pfizer Investigational Site, Lubbock,  Texas,  79424,  United States; Recruiting

      Pfizer Investigational Site, San Antonio,  Texas,  78229,  United States; No longer recruiting

      Pfizer Investigational Site, Dallas,  Texas,  75246,  United States; Recruiting

      Pfizer Investigational Site, Richardson,  Texas,  75080,  United States; Recruiting

Utah
      Pfizer Investigational Site, Salt Lake City,  Utah,  84102,  United States; Recruiting

Vermont
      Pfizer Investigational Site, Woodstock,  Vermont,  05091,  United States; Recruiting

Virginia
      Pfizer Investigational Site, Virginia Beach,  Virginia,  23454,  United States; Recruiting

Washington
      Pfizer Investigational Site, Seattle,  Washington,  98104,  United States; Recruiting

      Pfizer Investigational Site, Seattle,  Washington,  98122,  United States; Recruiting

      Pfizer Investigational Site, Yakima,  Washington,  98902,  United States; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A0081057
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151528
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Page Updated: October 15, 2009
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