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Tracking Information | |||||
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First Received Date † | September 1, 2005 | ||||
Last Updated Date | November 17, 2008 | ||||
Start Date † | September 2004 | ||||
Current Primary Outcome Measures † |
Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00143377 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Other safety and efficacy measures at 12 weeks of treatment. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
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). | ||||
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. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Urinary Incontinence | ||||
Intervention † | Drug: tolterodine SR, overactive bladder | ||||
Study Arms / Comparison Groups | |||||
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. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 600 | ||||
Completion Date | October 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00143377 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Pfizer | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Pfizer | ||||
Verification Date | December 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |