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

Urinary Bladder, Overactive Clinical Trial

Official title:

Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646880
• Other study ID #: DETAOD-0084-055
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2008
• Last updated: March 28, 2008
• Start date: March 2003
• Est. completion date: August 2003

Study information

• Verified date: March 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of detrusor activity, occurring throughout the duration of comparable AUM		28 days	No
Secondary	Number of pads used per 24 hours		28 days	No
Secondary	Urge Incontinence		28 days	No
Secondary	Number of urgency episodes		28 days	No
Secondary	Number of micturitions per 24 hours		28 days	No
Secondary	Volume voided per micturition		28 days	No
Secondary	Patient's perception of bladder condition		28 days	No
Secondary	Patient's perception of treatment benefit		28 days	No
Secondary	Patient's perception of urgency		28 days	No
Secondary	The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.		42 days	Yes

External Links

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