Back to resultsStudy to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tolterodine SR, overactive bladder
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.
Secondary Outcome Measures
Other safety and efficacy measures at 12 weeks of treatment.
Full Information
NCT ID
NCT00143377
First Posted
September 1, 2005
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00143377
Brief Title
Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tolterodine SR, overactive bladder
Primary Outcome Measure Information:
Title
Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.
Secondary Outcome Measure Information:
Title
Other safety and efficacy measures at 12 weeks of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19032133
Citation
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.
Results Reference
derived
Learn more about this trial
Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB
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