An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.

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NCT00138749

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Study Location
Pfizer Investigational Site
Anchorage, Alaska, 99508, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stress Urinary Incontinence
Sex
Female
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

- Clinically significant stress urinary incontinence

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


- History or evidence of any relevant confounding urological or neurological disease

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Stress Urinary IncontinenceAn 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
NCT00138749
  1. Anchorage, Alaska
  2. Sun City, Arizona
  3. Tucson, Arizona
  4. Tucson, Arizona
  5. Little Rock, Arkansas
  6. Atherton, California
  7. Carmichael, California
  8. Laguna Woods, California
  9. Murrieta, California
  10. Newport Beach, California
  11. Sacramento, California
  12. San Diego, California
  13. Tarzana, California
  14. Temecula, California
  15. Torrance, California
  16. Vista, California
  17. Aurora, Colorado
  18. Denver, Colorado
  19. Denver, Colorado
  20. Wheat Ridge, Colorado
  21. New London, Connecticut
  22. Waterbury, Connecticut
  23. Aventura, Florida
  24. New Port Richey, Florida
  25. Panama City, Florida
  26. Panama City, Florida
  27. Pembroke Pines, Florida
  28. Port Richey, Florida
  29. West Palm Beach, Florida
  30. Alpharetta, Georgia
  31. Coeur D Alene, Idaho
  32. Arlington Heights, Illinois
  33. Chicago, Illinois
  34. Melrose Park, Illinois
  35. Greenwood, Indiana
  36. Indianapolis, Indiana
  37. Des Moines, Iowa
  38. Louisville, Kentucky
  39. Shreveport, Louisiana
  40. Greenbelt, Maryland
  41. Watertown, Massachusetts
  42. Jackson, Mississippi
  43. Jackson, Mississippi
  44. Liberty, Missouri
  45. North Kansas City, Missouri
  46. Omaha, Nebraska
  47. Henderson, Nevada
  48. Edison, New Jersey
  49. West Orange, New Jersey
  50. Albuquerque, New Mexico
  51. Albany, New York
  52. Garden City, New York
  53. Garden City, New York
  54. Mineola, New York
  55. Poughkeepsie, New York
  56. Burlington, North Carolina
  57. Charlotte, North Carolina
  58. Concord, North Carolina
  59. Fayetteville, North Carolina
  60. Winston-salem, North Carolina
  61. Cincinnati, Ohio
  62. Bethany, Oklahoma
  63. Eugene, Oregon
  64. Eugene, Oregon
  65. Medford, Oregon
  66. Portland, Oregon
  67. Colmar, Pennsylvania
  68. Lancaster, Pennsylvania
  69. Philadelphia, Pennsylvania
  70. Pittsburgh, Pennsylvania
  71. Sellersville, Pennsylvania
  72. Sewickley, Pennsylvania
  73. Providence, Rhode Island
  74. Charleston, South Carolina
  75. Columbia, South Carolina
  76. Greer, South Carolina
  77. Myrtle Beach, South Carolina
  78. Knoxville, Tennessee
  79. Knoxville, Tennessee
  80. Corpus Christi, Texas
  81. Corsicana, Texas
  82. Houston, Texas
  83. San Antonio, Texas
  84. Salt Lake City, Utah
  85. Sandy, Utah
  86. Sandy, Utah
  87. West Jordan, Utah
  88. Virginia Beach, Virginia
  89. Seattle, Washington
  90. Surrey, British Columbia
  91. Victoria, British Columbia
  92. Kitchener, Ontario
  93. Oakville, Ontario
  94. Montreal, Quebec
  95. Pointe-Claire, Quebec
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
Official Title  ICMJE An 8-Week, Multi-Centre,Randomised Double-Blind, Placebo Controlled, Parallel Group Study To Evaluate The Efficacy,Toleration And Safety Of (+)- [S,S]- Reboxetine In The Treatment Of Stress Urinary Incontinence (SUI) In Women.
Brief Summary A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence, Stress
Intervention  ICMJE Drug: SS-RBX
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: August 26, 2005)		402
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically significant stress urinary incontinence

Exclusion Criteria:

  • History or evidence of any relevant confounding urological or neurological disease
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 65 Years   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00138749
Other Study ID Numbers  ICMJE A6061023
Has Data Monitoring Committee Not Provided
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 April 2011

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