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

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ClinicalTrials.gov Identifier: NCT00143377
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : November 18, 2008
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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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: tolterodine SR, overactive bladder Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2004
Estimated Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.

Secondary Outcome Measures :
  1. Other safety and efficacy measures at 12 weeks of treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143377

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00143377     History of Changes
Other Study ID Numbers: A6121122
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: November 18, 2008
Last Verified: December 2006

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents