Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet

NCT00139724

Last updated date
Study Location
Pfizer Investigational Site
Beijing, Beijing, 100020, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urinary Incontinence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with a diagnosis of overactive bladder.

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


- Subjects with significant stress incontinence as determined by the investigator.


- Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times
in the last year.

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  2. Beijing, Beijing
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  4. Beijing,
  5. Chongqing,
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  2. Phoenix, Arizona
  3. Little Rock, Arkansas
  4. Berkeley, California
  5. Oakland, California
  6. San Diego, California
  7. San Francisco, California
  8. Santa Rosa, California
  9. Denver, Colorado
  10. Denver, Colorado
  11. Lakewood, Colorado
  12. Farmington, Connecticut
  13. West Hartford, Connecticut
  14. Clearwater, Florida
  15. Leesburg, Florida
  16. Miami, Florida
  17. Pembroke Pines, Florida
  18. West Palm Beach, Florida
  19. Weston, Florida
  20. Alpharetta, Georgia
  21. Evansville, Indiana
  22. Newburgh, Indiana
  23. South Bend, Indiana
  24. Baton Rouge, Louisiana
  25. Metairie, Louisiana
  26. Metairie, Louisiana
  27. Baltimore, Maryland
  28. Saginaw, Michigan
  29. Creve Coeur, Missouri
  30. Las Vegas, Nevada
  31. Las Vegas, Nevada
  32. North Las Vegas, Nevada
  33. New Brunswick, New Jersey
  34. Albuquerque, New Mexico
  35. Olean, New York
  36. New Bern, North Carolina
  37. Winston-Salem, North Carolina
  38. Cincinnati, Ohio
  39. Cincinnati, Ohio
  40. Cleveland, Ohio
  41. Cleveland, Ohio
  42. Columbus, Ohio
  43. Gallipolis, Ohio
  44. Allentown, Pennsylvania
  45. Philadelphia, Pennsylvania
  46. Columbia, South Carolina
  47. Austin, Texas
  48. Austin, Texas
  49. Austin, Texas
  50. Bryan, Texas
  51. Conroe, Texas
  52. Irving, Texas
  53. San Antonio, Texas
  54. Salt Lake City, Utah
  55. Salt Lake City, Utah
  56. Seattle, Washington
  57. Morgantown, West Virginia
  58. Morgantown, West Virginia
Female
18 Years+
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MULTIPLE SITES
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  8. Oceanside, California
  9. Paramount, California
  10. Sacramento, California
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  15. Hallandale, Florida
  16. Orlando, Florida
  17. Wellington, Florida
  18. Woodstock, Georgia
  19. Libertyville, Illinois
  20. Mattoon, Illinois
  21. Newton, Kansas
  22. Milford, Massachusetts
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  24. St. Louis, Missouri
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  26. Albuquerque, New Mexico
  27. Albany, New York
  28. Bronx, New York
  29. Endwell, New York
  30. Garden City, New York
  31. Poughkeepsie, New York
  32. Greensboro, North Carolina
  33. Hickory, North Carolina
  34. Raleigh, North Carolina
  35. Canton, Ohio
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  41. Philadelphia, Pennsylvania
  42. Williamsport, Pennsylvania
  43. Mount Pleasant, South Carolina
  44. Simpsonville, South Carolina
  45. Bartlett, Tennessee
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  47. New Tazewell, Tennessee
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  8. Long Beach, California
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  16. Denver, Colorado
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  22. Tallahassee, Florida
  23. Wellington, Florida
  24. Atlanta, Georgia
  25. Columbus, Georgia
  26. Roswell, Georgia
  27. Melrose Park, Illinois
  28. Evansville, Indiana
  29. Jeffersonville, Indiana
  30. Iowa City, Iowa
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  34. Brighton, Massachusetts
  35. Watertown, Massachusetts
  36. Columbia, Missouri
  37. O'Fallon, Missouri
  38. St. Louis, Missouri
  39. Missoula, Montana
  40. Henderson, Nevada
  41. Las Vegas, Nevada
  42. Cherry Hill, New Jersey
  43. Edison, New Jersey
  44. Hamilton, New Jersey
  45. Lawrenceville, New Jersey
  46. Marlton, New Jersey
  47. Mt. Laurel, New Jersey
  48. Sewell, New Jersey
  49. Voorhees, New Jersey
  50. Westhampton, New Jersey
  51. Woodbury, New Jersey
  52. ALbuquerque, New Mexico
  53. Albany, New York
  54. Bayshore, New York
  55. Carmel, New York
  56. Cortlandt Manor, New York
  57. Garden City, New York
  58. Manhasset, New York
  59. New York, New York
  60. Orchard Park, New York
  61. Poughkeepsie, New York
  62. Staten Island, New York
  63. Syracuse, New York
  64. Cincinnati, Ohio
  65. Cleveland, Ohio
  66. Columbus, Ohio
  67. Oklahoma City, Oklahoma
  68. Portland, Oregon
  69. Allentown, Pennsylvania
  70. Bala Cynwyd, Pennsylvania
  71. Bryn Mawr, Pennsylvania
  72. Philadelphia, Pennsylvania
  73. State College, Pennsylvania
  74. Wynnewood, Pennsylvania
  75. Providence, Rhode Island
  76. Charleston, South Carolina
  77. Greenwood, South Carolina
  78. Greer, South Carolina
  79. Prosperity, South Carolina
  80. Saluda, South Carolina
  81. Germantown, Tennessee
  82. Milan, Tennessee
  83. Arlington, Texas
  84. Austin, Texas
  85. Houston, Texas
  86. San Antonio, Texas
  87. Provo, Utah
  88. Alexandria, Virginia
  89. Arlington, Virginia
  90. Charlotesville, Virginia
  91. Fairfax, Virginia
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Male
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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet
Official Title  ICMJE A Phase III Randomized, Double-Blind, Double Dummy, Multi-Center Study To Compare The Efficacy, Safety And Tolerability Of Tolterodine Extended Release Capsule With Tolterodine Immediate Release Tablet In Subjects With Symptoms Of Overactive Bladder
Brief Summary To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder
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 Urinary Incontinence
Intervention  ICMJE Drug: tolterodine extended release capsule
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
Actual Enrollment  ICMJE
 (submitted: December 18, 2009)
260
Original Enrollment  ICMJE
 (submitted: August 29, 2005)
240
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a diagnosis of overactive bladder.

Exclusion Criteria:

  • Subjects with significant stress incontinence as determined by the investigator.
  • Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139724
Other Study ID Numbers  ICMJE A6121112
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 December 2009

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