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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139724

Enrollment

260

Registered

2005-08-31

Start date

2005-05-31

Completion date

2006-10-31

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Brief summary

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

Interventions

DRUGtolterodine extended release capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026