Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB

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NCT00143377

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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 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 18 years or older patients suffering from OAB symptoms (urinary frequency of at least 8 micturitions per 24h, urinary urgency and at least 3 urge urinary incontinence episodes within 3 days), confirmed by a micturition bladder diary.

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


- Other than urge incontinence


- History of prostate/uterine or other female organ cancer

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB
Official Title  ICMJE A Global Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial To Evaluate The Effectiveness Of Detrusitol Sr 4mg On Patient's Perception Of Bladder Condition (PPBC).
Brief Summary The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder and which of these bothersome symptoms are improved with treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE Drug: tolterodine SR, overactive bladder
Study Arms  ICMJE Not Provided
Publications * Herschorn S, Heesakkers J, Castro-Diaz D, Wang JT, Brodsky M, Guan Z; Disease Management Study Team. Effects of tolterodine extended release on patient perception of bladder condition and overactive bladder symptoms*. Curr Med Res Opin. 2008 Dec;24(12):3513-21. doi: 10.1185/03007990802537122 .

*   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: September 1, 2005)		600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older patients suffering from OAB symptoms (urinary frequency of at least 8 micturitions per 24h, urinary urgency and at least 3 urge urinary incontinence episodes within 3 days), confirmed by a micturition bladder diary.

Exclusion Criteria:

  • Other than urge incontinence
  • History of prostate/uterine or other female organ cancer
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143377
Other Study ID Numbers  ICMJE A6121122
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's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

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