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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139724
• Other study ID #: A6121112
• Status: Completed
• Phase: Phase 3
• Start date: May 2005
• Est. completion date: October 2006

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Drug:
• tolterodine extended release capsule

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing	Beijing
China	Pfizer Investigational Site	Beijing	Beijing
China	Pfizer Investigational Site	Chongqing
China	Pfizer Investigational Site	Huangzhou	Zhejiang
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

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