Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Sponsor

Lee's Pharmaceutical Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01512004

Collaborator

APOGEPHA Arzneimittel GmbH (Industry)

324

Enrollment

Location

Arms

Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Propiverine Hydrochloride Drug: Tolterodine Extended-release Tablet	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propiverine Hydrochloride Extended-Release Capsule 30 mg/capsule; oral; once per day	Drug: Propiverine Hydrochloride drug of oral capsule Other Names: Mictonorm Propierine Hydrochloride Extended-Release Capsule
Placebo Comparator: Tolterodine Extended-release Tablet 4mg/tablet; oral; once per day	Drug: Tolterodine Extended-release Tablet 4mg/tablet; oral; once per day

Arm

Intervention/Treatment

Active Comparator: Propiverine Hydrochloride Extended-Release Capsule

30 mg/capsule; oral; once per day

Drug: Propiverine Hydrochloride

drug of oral capsule

Other Names:

Mictonorm

Propierine Hydrochloride Extended-Release Capsule

Placebo Comparator: Tolterodine Extended-release Tablet

4mg/tablet; oral; once per day

Drug: Tolterodine Extended-release Tablet

4mg/tablet; oral; once per day

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.