A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.

NCT01302054

Last updated date
Study Location
Radiant Research, Inc.
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Urinary Bladder
Sex
Females and Males
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

- Diagnosis of overactive bladder with symptoms for at least 6 months.

- Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine

- Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception

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


- Conditions or prior treatment that may also affect bladder function


- Clinically significant urinary tract infection (UTI)


- Ongoing treatment with overactive bladder medications (these can be stopped at the
first visit to allow entry into the study).

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Overactive Urinary BladderA Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.
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  1. Wien,
  2. Antwerpen,
  3. Edegem,
  4. Gent,
  5. Kortrijk,
  6. Aarhus N,
  7. Glostrup,
  8. Helsinki,
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  10. OYS,
  11. Tampere,
  12. Turku,
  13. Berlin,
  14. Berlin,
  15. Frankfurt,
  16. Hannover,
  17. Leipzig,
  18. Muenchen,
  19. Haifa,
  20. Haifa,
  21. Jerusalem,
  22. Foggia,
  23. Terracina, LT,
  24. Hamar,
  25. Oslo,
  26. Tonsberg,
  27. Trondheim,
  28. Coimbra,
  29. Lisboa,
  30. Porto,
  31. Porto,
  32. Porto,
  33. Bratislava,
  34. Bratislava,
  35. Galanta,
  36. Kosice - Saca,
  37. Kosice,
  38. Martorell, Barcelona
  39. Sabadell, Barcelona
  40. Getafe, Madrid
  41. Manacor, Palma de Mallorca
  42. Valencia,
  43. Eslov,
  44. Goteborg,
  45. Malmo,
  46. Malmo,
  47. Norrkoping,
  48. Stockholm,
  49. Frauenfeld,
  50. Ankara,
  51. Istanbul,
  52. Izmir,
  53. Samsun,
  54. Bexhill on Sea, East Sussex
  55. Leytonstone, London
  56. Harrow, Middlesex
  57. High Heaton, Newcastle upon Tyne
  58. Birmingham,
  59. London,
  60. London,
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Overactive Urinary BladderA Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
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  6. Phoenix, Arizona
  7. Sun Lakes, Arizona
  8. Bentonville, Arkansas
  9. Jonesboro, Arkansas
  10. Little Rock, Arkansas
  11. Buena Park, California
  12. Foothill Ranch, California
  13. Fresno, California
  14. West Covina, California
  15. Colorado Springs, Colorado
  16. Lakewood, Colorado
  17. Chipley, Florida
  18. Davie, Florida
  19. Hallandale, Florida
  20. Miami Beach, Florida
  21. Miami, Florida
  22. Murdock, Florida
  23. Ocala, Florida
  24. Pembroke Pines, Florida
  25. St. Cloud, Florida
  26. Tampa, Florida
  27. Atlanta, Georgia
  28. Barnesville, Georgia
  29. Blue Ridge, Georgia
  30. Decatur, Georgia
  31. Chicago, Illinois
  32. Naperville, Illinois
  33. Orland Park, Illinois
  34. Newton, Kansas
  35. Shawnee, Kansas
  36. Wichita, Kansas
  37. Wichita, Kansas
  38. Marrero, Louisiana
  39. Laurel, Maryland
  40. Oxon Hill, Maryland
  41. Jackson, Michigan
  42. Portage, Michigan
  43. St. Louis, Missouri
  44. Las Vegas, Nevada
  45. Las Vegas, Nevada
  46. Blackwood, New Jersey
  47. Mt. Laurel, New Jersey
  48. Binghamton, New York
  49. Endicott, New York
  50. Endwell, New York
  51. Kingston, New York
  52. Beaufort, North Carolina
  53. Charlotte, North Carolina
  54. Charlotte, North Carolina
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  58. Columbus, Ohio
  59. Kettering, Ohio
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  62. Bala Cynwyd, Pennsylvania
  63. Bensalem, Pennsylvania
  64. Connellsville, Pennsylvania
  65. Philadelphia, Pennsylvania
  66. Philadelphia, Pennsylvania
  67. Philadelphia, Pennsylvania
  68. Sellersville, Pennsylvania
  69. Stoneboro, Pennsylvania
  70. Warwick, Rhode Island
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  72. Simpsonville, South Carolina
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  74. Huntingdon, Tennessee
  75. Lexington, Tennessee
  76. Savannah, Tennessee
  77. Selmer, Tennessee
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  85. Plano, Texas
  86. San Antonio, Texas
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  88. Salt Lake City, Utah
  89. West Jordan, Utah
  90. West Valley City, Utah
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  92. Spokane, Washington
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Official Title  ICMJE A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
Brief Summary Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE
  • Drug: Fesoterodine 8 mg
    Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
    Other Name: Toviaz
  • Drug: Placebo
    Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.
Study Arms  ICMJE
  • Experimental: Fesoterodine
    Intervention: Drug: Fesoterodine 8 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Kaplan SA, Cardozo L, Herschorn S, Grenabo L, Carlsson M, Arumi D, Crook TJ, Whelan L, Scholfield D, Ntanios F; Assessment of Fesoterodine after Tolterodine ER (AFTER) Study Group. Efficacy and safety of fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine ER. Int J Clin Pract. 2014 Sep;68(9):1065-73. doi: 10.1111/ijcp.12464. Epub 2014 Jun 4.

*   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: March 22, 2013)
990
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2011)
3143
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of overactive bladder with symptoms for at least 6 months.
  • Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
  • Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception

Exclusion Criteria:

  • Conditions or prior treatment that may also affect bladder function
  • Clinically significant urinary tract infection (UTI)
  • Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 Bulgaria,   Canada,   Czechia,   Egypt,   Finland,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   South Africa,   Sweden,   Ukraine,   United States
Removed Location Countries Czech Republic,   Greece,   Italy,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01302054
Other Study ID Numbers  ICMJE A0221094
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
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