Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.

Back to Search
Print
Bookmark Trial

NCT00333866

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Warrawong, New South Wales, 2502, Australia
See other locations
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]

Call Now

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

- ACR criteria for fibromyalgia

- A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

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


- Patients with other severe pain conditions


- Patients with severe depression


- Patients taking excluded medications

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

FibromyalgiaFibromyalgia of Less Than One Year Duration. Study of Pregabalin
NCT01397006
  1. Newton, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
FibromyalgiaFixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
NCT01226667
  1. Beverly Hills, California
  2. Beverly Hills, California
  3. Huntington Beach, California
  4. Tucson, California
  5. West Hills, California
Female
18 Years+
years
MULTIPLE SITES
FibromyalgiaOnline Mindfulness Training Versus Health Education for Fibromyalgia
NCT01748786
  1. Tempe, Arizona
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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
Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
Official Title  ICMJE A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.
Brief Summary This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: pregabalin
    600mg/day
  • Drug: pregabalin
    450mg/day
  • Drug: pregabalin
    300mg/day
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Experimental: 2
    Intervention: Drug: pregabalin
  • Experimental: 3
    Intervention: Drug: pregabalin
  • Placebo Comparator: 4
    Intervention: Drug: placebo
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: March 26, 2009)		747
Original Enrollment  ICMJE
 (submitted: June 2, 2006)		740
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ACR criteria for fibromyalgia
  • A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

  • Patients with other severe pain conditions
  • Patients with severe depression
  • Patients taking excluded medications
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 Australia,   Canada,   Denmark,   France,   Germany,   India,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Portugal,   Spain,   Sweden,   Switzerland,   United Kingdom,   Venezuela
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT00333866
Other Study ID Numbers  ICMJE A0081100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

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