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NCT00143377 Clinical Trial

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

Urinary Incontinence Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143377
Other study ID # A6121122
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2004
Est. completion date October 2005

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tolterodine SR, overactive bladder

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.
Secondary Other safety and efficacy measures at 12 weeks of treatment.
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