Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Propiverine Hydrochloride; Drug: Tolterodine Extended-release Tablet

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 Type: Interventional
• Enrollment (Actual): 324
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Chaoyang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Collaborators: APOGEPHA Arzneimittel GmbH
• Investigators: Study Director: Benjamin Li, PhD, Lee's Pharmaceutical

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: November 24, 2010
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): January 25, 2012
• Last Update Submitted That Met QC Criteria: January 24, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Overactive Bladder; urgent micturition; frequent micturition; urge urinary incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Tolterodine Tartrate; Propiverine
• Other Study ID Numbers: LEES-MIC