Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Propiverine Hydrochloride
* Drug: Tolterodine Extended-release Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propiverine Hydrochloride Extended-Release Capsule<br>30 mg/capsule; oral; once per day | Drug: Propiverine Hydrochloride<br>* drug of oral capsule<br>* Other names: Propierine Hydrochloride Extended-Release Capsule;|
| Placebo Comparator: Tolterodine Extended-release Tablet<br>4mg/tablet; oral; once per day | Drug: Tolterodine Extended-release Tablet<br>* 4mg/tablet; oral; once per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record | 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 | prior to medication and 8 weeks after medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record | 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. | prior to medication, 2 weeks and 8 weeks after medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, urgent micturition, frequent micturition, urge urinary incontinence