Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.

NCT00658684

Last updated date
Study Location
Pfizer Investigational Site
Inegeku, Chibashi, Chiba-ken, , Japan
Contact
1-800-718-1021

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By email

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

- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=1 per day.

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


- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or
to peanut or soya or any of the excipients.


- Patient has a known neurological disease influencing bladder function.


- Patient has a complication of lower urinary tract pathology potentially responsible
for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic
organ prolapse.

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  4. Orangevale, California
  5. Aurora, Colorado
  6. West Palm Beach, Florida
  7. Aurora, Illinois
  8. Pratt, Kansas
  9. Shreveport, Louisiana
  10. Milford, Massachusetts
  11. Omaha, Nebraska
  12. Westampton, New Jersey
  13. Kingston, New York
  14. New York, New York
  15. Poughkeepsie, New York
  16. Winston-Salem, North Carolina
  17. Cincinnati, Ohio
  18. Bethany, Oklahoma
  19. Eugene, Oregon
  20. Sellersville, Pennsylvania
  21. Houston, Texas
  22. Salt Lake City, Utah
  23. Salt Lake City, Utah
  24. Milwaukee, Wisconsin
  25. Bruxelles,
  26. Edegem,
  27. Gent,
  28. Jette,
  29. Turnhout,
  30. Alajuela Centro, Alajuela
  31. San Jose,
  32. Brno-Bohunice,
  33. Hradec Kralove,
  34. Praha 2,
  35. Praha 5,
  36. Alzey,
  37. Berlin,
  38. Duisburg,
  39. Frankfurt,
  40. Marburg,
  41. Muelheim A.d. Ruhr,
  42. Muenchen,
  43. Bucheon-si, Gyunggi-do
  44. Busan,
  45. Daejeon,
  46. Jeonnam,
  47. Seoul,
  48. Seoul,
  49. Lodz,
  50. Myslowice,
  51. Bratislava,
  52. Malacky,
  53. Piestany,
  54. Presov,
  55. Skalica,
  56. Chernivtsi,
  57. Dnipropetrovsk,
  58. Kharkiv,
  59. Odessa,
  60. Zaporizhzhia,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
Official Title  ICMJE An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
Brief Summary To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE Drug: fesoterodine fumarate
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
Study Arms  ICMJE Experimental: Fesoterodine fumarate
Intervention: Drug: fesoterodine fumarate
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: September 29, 2009)
153
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2008)
150
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=1 per day.

Exclusion Criteria:

  • Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
  • Patient has a known neurological disease influencing bladder function.
  • Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00658684
Other Study ID Numbers  ICMJE A0221006
A0221006
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 October 2010

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