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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 1, 2005
Last updated: November 17, 2008
Last verified: December 2006
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00143377

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00143377     History of Changes
Other Study ID Numbers: A6121122
Study First Received: September 1, 2005
Last Updated: November 17, 2008

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 processed this record on March 27, 2017