An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

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NCT00151528

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-3405, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056

- Must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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FibromyalgiaAn Open-Label Trial of Pregabalin in Patients With Fibromyalgia NCT00151528
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Huntsville, Alabama
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Scottsdale, Arizona
  7. Hot Springs, Arkansas
  8. Little Rock, Arkansas
  9. Beverly Hills, California
  10. Los Alamitos, California
  11. Newport Beach, California
  12. Northridge, California
  13. Pismo Beach, California
  14. Redondo Beach, California
  15. Riverside, California
  16. Walnut Creek, California
  17. Whittier, California
  18. Danbury, Connecticut
  19. New Milford, Connecticut
  20. Stratford, Connecticut
  21. Clearwater, Florida
  22. Miami, Florida
  23. Ocala, Florida
  24. Palm Beach Gardens, Florida
  25. Seminole, Florida
  26. St. Petersburg, Florida
  27. St. Petersburg, Florida
  28. St. Petersburg, Florida
  29. Sunrise, Florida
  30. West Palm Beach, Florida
  31. Atlanta, Georgia
  32. Decatur, Georgia
  33. Boise, Idaho
  34. Chicago, Illinois
  35. Maywood, Illinois
  36. Oak Brook, Illinois
  37. Peoria, Illinois
  38. Kansas City, Kansas
  39. Overland Park, Kansas
  40. Madisonville, Kentucky
  41. New Orleans, Louisiana
  42. Newton, Massachusetts
  43. Kalamazoo, Michigan
  44. Lansing, Michigan
  45. Kansas City, Missouri
  46. Lebanon, New Hampshire
  47. Princeton, New Jersey
  48. Albany, New York
  49. New York, New York
  50. Rochester, New York
  51. Charlotte, North Carolina
  52. Wilmington, North Carolina
  53. Wilmington, North Carolina
  54. Winston Salem, North Carolina
  55. Winston-Salem, North Carolina
  56. Cincinnati, Ohio
  57. Columbus, Ohio
  58. Columbus, Ohio
  59. Mogadore, Ohio
  60. Toledo, Ohio
  61. Oklahoma City, Oklahoma
  62. Eugene, Oregon
  63. Medford, Oregon
  64. Portland, Oregon
  65. Altoona, Pennsylvania
  66. Duncansville, Pennsylvania
  67. Johnstown, Pennsylvania
  68. Mechanicsburg, Pennsylvania
  69. Philadelphia, Pennsylvania
  70. Philadelphia, Pennsylvania
  71. Pittsburgh, Pennsylvania
  72. Pittsburgh, Pennsylvania
  73. Pittsburgh, Pennsylvania
  74. Pottstown, Pennsylvania
  75. West Reading, Pennsylvania
  76. Wyomissing, Pennsylvania
  77. Anderson, South Carolina
  78. Charleston, South Carolina
  79. Greer, South Carolina
  80. Memphis, Tennessee
  81. Memphis, Tennessee
  82. Nashville, Tennessee
  83. Austin, Texas
  84. Dallas, Texas
  85. Lubbock, Texas
  86. Richardson, Texas
  87. San Antonio, Texas
  88. San Antonio, Texas
  89. Salt Lake City, Utah
  90. Woodstock, Vermont
  91. Virginia Beach, Virginia
  92. Seattle, Washington
  93. Seattle, Washington
  94. Yakima, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
FibromyalgiaRandomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia. NCT00333866
  1. Warrawong, New South Wales
  2. Maroochydore, Queensland
  3. Clayton, Victoria
  4. Fitzroy, Victoria
  5. Kelowna, British Columbia
  6. Winnipeg, Manitoba
  7. Bathurst, New Brunswick
  8. Saint John's, Newfoundland and Labrador
  9. Hawkesbury, Ontario
  10. Toronto, Ontario
  11. Drummondville, Quebec
  12. Montreal, Quebec
  13. Pointe Claire, Quebec
  14. Sherbrooke, Quebec
  15. Sherbrooke, Quebec
  16. Quebec,
  17. Frederiksberg,
  18. Svendborg,
  19. Montpellier, Cedex 5
  20. Lille, Cedex
  21. Clermont Ferrand Cedex 1,
  22. Paris Cedex 04,
  23. Saint Etienne Cedex 2,
  24. Bad Saeckingen,
  25. Berlin,
  26. Berlin,
  27. Bonn,
  28. Mannheim,
  29. Muenchen,
  30. Indore, Madhya Pradesh
  31. Ludhiana, Punjab
  32. Ludhiana, Punjab
  33. Lucknow, Uttar Pradesh
  34. Bari,
  35. Benevento,
  36. Bologna,
  37. Chieti Scalo,
  38. Perugia,
  39. Pisa,
  40. Suwon-si, Kyeongki-do
  41. Seoul,
  42. Seoul,
  43. Mexico, D. F.
  44. Leon, Guanajuato
  45. Monterrey, Nuevo Leon
  46. San Luis Potosi,
  47. Alkmaar,
  48. Den Helder,
  49. Leeuwarden,
  50. Rotterdam,
  51. Zwolle,
  52. Lisboa,
  53. Lisboa,
  54. Lisboa,
  55. Lisbon,
  56. Barcelona,
  57. Barcelona,
  58. Cordoba,
  59. Guadalajara,
  60. Linkoping,
  61. Molndal,
  62. Orebro,
  63. Stockholm,
  64. Lausanne,
  65. Zurich,
  66. Zürich,
  67. Manchester, Greater Manchester
  68. Greenock, Renfrewshire
  69. North Shields, Tyne and Wear
  70. London,
  71. Poole,
  72. Caracas, Distrito Capital
  73. Caracas, Distrito Capital
  74. Caracas, Estado Miranda
ALL GENDERS
18 Years+
years
MULTIPLE SITES
FibromyalgiaA Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia. NCT00752505
  1. Destin, Florida
  2. Fort Walton Beach, Florida
  3. Ann Arbor, Michigan
  4. Bingham Farms, Michigan
  5. Oklahoma City, Oklahoma
  6. Austin, Texas
  7. Dallas, Texas
ALL GENDERS
18 Years+
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MULTIPLE SITES
FibromyalgiaA Safety Study Of Pregabalin In Fibromyalgia NCT00282997
  1. Little Rock, Arkansas
  2. Fresno, California
  3. La Jolla, California
  4. Northridge, California
  5. Pismo Beach, California
  6. Sacramento, California
  7. San Diego, California
  8. Walnut Creek, California
  9. Newark, Delaware
  10. DeLand, Florida
  11. Gainesville, Florida
  12. Hollywood, Florida
  13. Melbourne, Florida
  14. Ocala, Florida
  15. Palm Harbor, Florida
  16. Sunrise, Florida
  17. Tampa, Florida
  18. West Palm Beach, Florida
  19. Gurnee, Illinois
  20. Moline, Illinois
  21. Indianapolis, Indiana
  22. Dubuque, Iowa
  23. Prairie Village, Kansas
  24. Pratt, Kansas
  25. Lexington, Kentucky
  26. Kenner, Louisiana
  27. Metairie, Louisiana
  28. N. Dartmouth, Massachusetts
  29. Watertown, Massachusetts
  30. Worcester, Massachusetts
  31. Chaska, Minnesota
  32. St. Paul, Minnesota
  33. Jefferson City, Missouri
  34. Kanas City, Missouri
  35. St. Louis, Missouri
  36. Lincoln, Nebraska
  37. Morristown, New Jersey
  38. Albany, New York
  39. Endwell, New York
  40. New York, New York
  41. West Seneca, New York
  42. Asheville, North Carolina
  43. Hickory, North Carolina
  44. Raleigh, North Carolina
  45. Salisbury, North Carolina
  46. Winston-Salem, North Carolina
  47. Minot, North Dakota
  48. Cincinnati, Ohio
  49. Dayton, Ohio
  50. Tulsa, Oklahoma
  51. Bethlehem, Pennsylvania
  52. Norristown, Pennsylvania
  53. Goose Creek, South Carolina
  54. Mount Pleasant, South Carolina
  55. Mt Pleasant, South Carolina
  56. Mt. Pleasant, South Carolina
  57. Myrtle Beach, South Carolina
  58. Summerville, South Carolina
  59. Knoxville, Tennessee
  60. Milan, Tennessee
  61. Nashville, Tennessee
  62. Bedford, Texas
  63. Georgetown, Texas
  64. Houston, Texas
  65. Killeen, Texas
  66. Lake Jackson, Texas
  67. San Antonio, Texas
  68. Salt Lake City, Utah
  69. Woodstock, Vermont
  70. Virginia Beach, Virginia
  71. Everett, Washington
  72. Spokane, Washington
  73. Tacoma, Washington
  74. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
Official Title  ICMJE A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: Pregabalin
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 8, 2005)		428
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151528
Other Study ID Numbers  ICMJE A0081057
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP