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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: propiverine (Drug); tolterodine PR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome: Parameters of detrusor activity, occurring throughout the duration of comparable AUM

Secondary outcome:

Number of pads used per 24 hours

Urge Incontinence

Number of urgency episodes

Number of micturitions per 24 hours

Volume voided per micturition

Patient's perception of bladder condition

Patient's perception of treatment benefit

Patient's perception of urgency

The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2003
Last updated: March 28, 2008

Page last updated: August 23, 2015

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