A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

Back to Search
Print
Bookmark Trial

NCT00696787

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Huntsville, Alabama, 35801, 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
Female
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

- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

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


- Unstable medical or psychological conditions that would compromise the subject's
safety or put the subject at greater risk during study participation


- Other painful conditions that may confound the diagnosis or assessment of fibromyalgia


- Treatment with other drugs for fibromyalgia with 14 days of study start or during the
study

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 A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome
Brief Summary The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: Desvenlafaxine Sustained Release (DVS SR)
  • Drug: Lyrica® (Pregabalin)
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor.
    Intervention: Drug: Placebo
  • Experimental: DVS SR
    In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor.
    Intervention: Drug: Desvenlafaxine Sustained Release (DVS SR)
  • Active Comparator: Pregabalin
    In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.
    Intervention: Drug: Lyrica® (Pregabalin)
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2010)		125
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2008)		420
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

Exclusion Criteria:

  • Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
  • Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
  • Treatment with other drugs for fibromyalgia with 14 days of study start or during the study
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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 NCT00696787
Other Study ID Numbers  ICMJE 3151A4-2003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

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