Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139724

Purpose

To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder

Condition	Intervention	Phase
Urinary Incontinence	Drug: tolterodine extended release capsule	Phase III

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, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	240
Study Start Date:	May 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139724

Locations

China
Pfizer Investigational Site
Beijing, China, 100034
Pfizer Investigational Site
Shanghai, China, 200040
Pfizer Investigational Site
Shanghai, China, 200127
Pfizer Investigational Site
Chongqing, China
Pfizer Investigational Site
Beijing, China, 100020
China, Zhejiang Province
Pfizer Investigational Site
Huangzhou, Zhejiang Province, China, 310003

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A6121112
Study First Received:	August 29, 2005
Last Updated:	October 16, 2006
ClinicalTrials.gov Identifier:	NCT00139724
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
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