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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143377

Purpose

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.

Condition	Intervention	Phase
Urinary Incontinence	Drug: tolterodine SR, overactive bladder	Phase IV

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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).

Further study details as provided by Pfizer:

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.

Estimated Enrollment:	600
Study Start Date:	September 2004
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143377

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

results.org This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Study ID Numbers:	A6121122
Study First Received:	September 1, 2005
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00143377
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Signs and Symptoms
Urologic Diseases
Urination Disorders
Urinary Incontinence
Tolterodine

Additional relevant MeSH terms:

Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009