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)
Verified date | March 2008 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | August 2003 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pfizer Investigational Site | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Korea, Republic of,
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 |
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