A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.

Back to Search
Print
Bookmark Trial

NCT00752505

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Destin, Florida, 32541, United States
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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender

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


- Other confounding pain, cognitive disease or impairment, disease that could put the
subject at risk or subjects who are on prohibited medications that cannot be washed
out.


- Any subjects with a diagnosis of certain psychiatric disorders in particular major
depression or suicidal risk. Matched control subjects have similar exclusions.

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
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

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 A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.
Official Title  ICMJE A Phase 2 Randomized Double-Blind Placebo-Controlled Crossover Study Assessing The Ability Of Esreboxetine (PNU-165442g) To Improve Cognitive Function In Fibromyalgia Patients.
Brief Summary The study is designed to assess if esreboxetine can improve the cognitive function of patients with fibromyalgia. Cognitive function is defined as the ability to concentrate, remember things and make decisions or problem solve. The study is also designed to assess if there is a difference in cognitive function between fibromyalgia patients and matched control subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Drug: Esreboxetine
Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Esreboxetine
  • Experimental: B
    Intervention: Drug: Esreboxetine
Publications * Not Provided

*   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: July 9, 2009)		89
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2008)		80
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender

Exclusion Criteria:

  • Other confounding pain, cognitive disease or impairment, disease that could put the subject at risk or subjects who are on prohibited medications that cannot be washed out.
  • Any subjects with a diagnosis of certain psychiatric disorders in particular major depression or suicidal risk. Matched control subjects have similar exclusions.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00752505
Other Study ID Numbers  ICMJE A6061061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2018

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