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
Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)
1 other identifier
interventional
41
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2003
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedMarch 31, 2008
March 1, 2008
March 26, 2008
March 28, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Parameters of detrusor activity, occurring throughout the duration of comparable AUM
28 days
Secondary Outcomes (9)
Number of pads used per 24 hours
28 days
Urge Incontinence
28 days
Number of urgency episodes
28 days
Number of micturitions per 24 hours
28 days
Volume voided per micturition
28 days
- +4 more secondary outcomes
Study Arms (2)
Propiverine/tolterodine group
ACTIVE COMPARATORTolerodine/propiverine group
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Seoul, 110-744, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
March 1, 2003
Study Completion
August 1, 2003
Last Updated
March 31, 2008
Record last verified: 2008-03