Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Lee's Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Overactive Bladder

Treatments

Drug: Tolterodine Extended-release Tablet

Drug: Propiverine Hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01512004

LEES-MIC

Details and patient eligibility

About

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.

Full 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.

Enrollment

324 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.