A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

Back to Search
Print
Bookmark Trial

NCT00645281

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35211, 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.
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

- self-reported symptoms of OAB for ≥ 3 months prior to screening

- OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)

- urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline

- patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

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


- any condition that would contraindicate their usage of tolterodine once daily,
including: narrow angle glaucoma, urinary retention, gastric retention


- any clinically significant local urinary tract pathology which could mimic the
symptoms of OAB, such as infection or hematuria


- stress incontinence, functional, or overflow incontinence as determined by the
investigator


- symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent
UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to
participation in this clinical trial


- clinically significant urinary tract obstruction


- history of lower urinary tract surgery (e.g. prostate removal or destruction,
incontinence surgery) within the past 3 months


- clinically significant interstitial cystitis or significant bladder pain syndrome

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

Overactive Urinary BladderA Study to Evaluate the Efficacy of Tolterodine Prolonged Release Compared With Propiverine for the Treatment of Korean Patients With Overactive Bladder as Assessed by Ambulatory Urodynamic Monitoring
NCT00646880
  1. Seoul,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
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.
NCT00798434
  1. Wien,
  2. Antwerpen,
  3. Edegem,
  4. Gent,
  5. Kortrijk,
  6. Aarhus N,
  7. Glostrup,
  8. Helsinki,
  9. Kouvola,
  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.
NCT00645281
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Huntsville, Alabama
  5. Montgomery, Alabama
  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
  55. Durham, North Carolina
  56. Morehead City, North Carolina
  57. Winston-Salem, North Carolina
  58. Columbus, Ohio
  59. Kettering, Ohio
  60. Central Point, Oregon
  61. Medford, Oregon
  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
  71. Greer, South Carolina
  72. Simpsonville, South Carolina
  73. Cordova, Tennessee
  74. Huntingdon, Tennessee
  75. Lexington, Tennessee
  76. Savannah, Tennessee
  77. Selmer, Tennessee
  78. Waynesboro, Tennessee
  79. Austin, Texas
  80. Bryan, Texas
  81. Colleyville, Texas
  82. Friendswood, Texas
  83. Houston, Texas
  84. Plano, Texas
  85. Plano, Texas
  86. San Antonio, Texas
  87. Salt Lake City, Utah
  88. Salt Lake City, Utah
  89. West Jordan, Utah
  90. West Valley City, Utah
  91. Spokane, Washington
  92. Spokane, Washington
  93. Milwaukee, Wisconsin
  94. New Berlin, Wisconsin
  95. Oregon, Wisconsin
  96. Wauwatosa, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Overactive Urinary BladderPharmacokinetics and Relative Bioavailability Study
NCT01521767
  1. Singapore,
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
Official Title  ICMJE Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-Label, Single-Arm, Non-Randomized, Trial in Adult Patients With OAB.
Brief Summary The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE Drug: tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks
Study Arms  ICMJE Experimental: tolterodine ER group
Intervention: Drug: tolterodine extended release
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: March 25, 2008)		896
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • self-reported symptoms of OAB for ? 3 months prior to screening
  • OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
  • urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
  • patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

  • any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
  • any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
  • stress incontinence, functional, or overflow incontinence as determined by the investigator
  • symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
  • clinically significant urinary tract obstruction
  • history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
  • clinically significant interstitial cystitis or significant bladder pain syndrome
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645281
Other Study ID Numbers  ICMJE A6121001
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 March 2008

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