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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

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.

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.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

600

Completion Date

October 2005

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00143377

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

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.