Overactive Bladder
Conditions
Keywords
Overactive Bladder, urgent micturition, frequent micturition, urge urinary incontinence
Brief summary
The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
Detailed description
This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
Interventions
drug of oral capsule
DRUGTolterodine Extended-release Tablet
4mg/tablet; oral; once per day
Sponsors
APOGEPHA Arzneimittel GmbH
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB\>3 months subject has urinary frequency (average micturition frequency within 24h\>8 times), urgency and/or urge incontinence by micturition diary card during screening period * Mean volume of single micturition is less than 200ml by micturition diary dard during screening period * The subject is willing and able to complete the micturition diary card correctly * Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form
Exclusion criteria
* Confirmed by the investigator that subject has severe stress incontinence. * Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll. * Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma. * Subject who has a symptomatic acute urinary tract infection. * Subject who has a recurrent urinary tract infection. * Subject who has interstitial cystitis. * Subject who has an agnogenic hematuria. * Subject who has a bladder outlet obstruction of clinical significance. * Subject who needs retention catheterization or intermittent catheterization. * Patient with malignant tumor. * Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins. * Subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days. * Women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record | prior to medication and 8 weeks after medication | The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record | prior to medication, 2 weeks and 8 weeks after medication | The alteration of mean incontinence frequency, mean micturition frequency and volume within 24 hous on the basis of continuous 3-day record,prior to medication, 2 weeks and 8 weeks after medication. Additionaly, to evaluate the subject's feeling of treatment benefit and the time of the drug effect onset. |
Countries
China
Outcome results
None listed