Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Overview

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 Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2010

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: Propiverine Hydrochloride
    • drug of oral capsule
  • Drug: Tolterodine Extended-release Tablet
    • 4mg/tablet; oral; once per day

Arms, Groups and Cohorts

  • Active Comparator: Propiverine Hydrochloride Extended-Release Capsule
    • 30 mg/capsule; oral; once per day
  • Placebo Comparator: Tolterodine Extended-release Tablet
    • 4mg/tablet; oral; once per day

Clinical Trial Outcome Measures

Primary Measures

  • Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record
    • Time Frame: 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 Measures

  • The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lee’s Pharmaceutical Limited
  • Collaborator
    • APOGEPHA Arzneimittel GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benjamin Li, PhD, Study Director, Lee’s Pharmaceutical

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