Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-08-31

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.

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propiverine Hydrochloride Extended-Release Capsule

30 mg/capsule; oral; once per day

Group Type ACTIVE_COMPARATOR

Propiverine Hydrochloride

Intervention Type DRUG

drug of oral capsule

Tolterodine Extended-release Tablet

4mg/tablet; oral; once per day

Group Type PLACEBO_COMPARATOR

Tolterodine Extended-release Tablet

Intervention Type DRUG

4mg/tablet; oral; once per day

Interventions

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Propiverine Hydrochloride

drug of oral capsule

Intervention Type DRUG

Tolterodine Extended-release Tablet

4mg/tablet; oral; once per day

Intervention Type DRUG

Other Intervention Names

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Mictonorm Propierine Hydrochloride Extended-Release Capsule

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No