Back to resultsA 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
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propiverine
tolterodine PR
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propiverine/tolterodine group
Tolerodine/propiverine group
Arm Description
Outcomes
Primary Outcome Measures
Parameters of detrusor activity, occurring throughout the duration of comparable AUM
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646880
Brief Title
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
Official Title
Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propiverine/tolterodine group
Arm Type
Active Comparator
Arm Title
Tolerodine/propiverine group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
propiverine
Intervention Description
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
Intervention Name(s)
tolterodine PR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parameters of detrusor activity, occurring throughout the duration of comparable AUM
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of pads used per 24 hours
Time Frame
28 days
Title
Urge Incontinence
Time Frame
28 days
Title
Number of urgency episodes
Time Frame
28 days
Title
Number of micturitions per 24 hours
Time Frame
28 days
Title
Volume voided per micturition
Time Frame
28 days
Title
Patient's perception of bladder condition
Time Frame
28 days
Title
Patient's perception of treatment benefit
Time Frame
28 days
Title
Patient's perception of urgency
Time Frame
28 days
Title
The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=DETAOD-0084-055&StudyName=A%20Study%20to%20Evaluate%20the%20Efficacy%20of%20Tolterodine%20Prolonged%20Release%20Compared%20with%20Propiverine%20for%20the%20Treatment%20of%20Korean%20Patients%20
Description
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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
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