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Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00139724
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : December 21, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: tolterodine extended release capsule Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-Blind, Double Dummy, Multi-Center Study To Compare The Efficacy, Safety And Tolerability Of Tolterodine Extended Release Capsule With Tolterodine Immediate Release Tablet In Subjects With Symptoms Of Overactive Bladder
Study Start Date : May 2005
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder

Secondary Outcome Measures :
  1. To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of overactive bladder.

Exclusion Criteria:

  • Subjects with significant stress incontinence as determined by the investigator.
  • Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.
Contacts and Locations

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): NCT00139724


Locations
China, Beijing
Pfizer Investigational Site
Beijing, Beijing, China, 100020
Pfizer Investigational Site
Beijing, Beijing, China, 100034
China, Zhejiang
Pfizer Investigational Site
Huangzhou, Zhejiang, China, 310003
China
Pfizer Investigational Site
Beijing, China, 100034
Pfizer Investigational Site
Chongqing, China
Pfizer Investigational Site
Shanghai, China, 200040
Pfizer Investigational Site
Shanghai, China, 200127
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00139724     History of Changes
Other Study ID Numbers: A6121112
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: December 21, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
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