A Study to Evaluate the Efficacy of Tolterodine Prolonged Release Compared With Propiverine for the Treatment of Korean Patients With Overactive Bladder as Assessed by Ambulatory Urodynamic Monitoring

NCT ID: NCT00646880

Last Updated: 2008-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2003-08-31

Brief Summary

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The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile.

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propiverine/tolterodine group

Group Type ACTIVE_COMPARATOR

propiverine

Intervention Type DRUG

Two week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.

Tolerodine/propiverine group

Group Type ACTIVE_COMPARATOR

tolterodine PR

Intervention Type DRUG

Two week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.

Interventions

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propiverine

Two week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.

Intervention Type DRUG

tolterodine PR

Two week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptoms of urinary urgency
* Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart
* Symptoms of overactive bladder for greater than or equal to 6 months

Exclusion Criteria

* Stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
* An average volume voided of \>200 ml per micturition as verified on the micturition chart before randomization
* Total daily urine volume of \>3000 ml as verified on the micturition chart before randomization
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

Other Identifiers

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DETAOD-0084-055

Identifier Type: -

Identifier Source: org_study_id