Back to resultsPropiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Propiverine Hydrochloride
Tolterodine Extended-release Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, urgent micturition, frequent micturition, urge urinary incontinence
Eligibility Criteria
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.
Sites / Locations
- Beijing Chaoyang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Propiverine Hydrochloride Extended-Release Capsule
Tolterodine Extended-release Tablet
Arm Description
30 mg/capsule; oral; once per day
4mg/tablet; oral; once per day
Outcomes
Primary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT01512004
First Posted
November 24, 2010
Last Updated
January 24, 2012
Sponsor
Lee's Pharmaceutical Limited
Collaborators
APOGEPHA Arzneimittel GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01512004
Brief Title
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
Collaborators
APOGEPHA Arzneimittel GmbH
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, urgent micturition, frequent micturition, urge urinary incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propiverine Hydrochloride Extended-Release Capsule
Arm Type
Active Comparator
Arm Description
30 mg/capsule; oral; once per day
Arm Title
Tolterodine Extended-release Tablet
Arm Type
Placebo Comparator
Arm Description
4mg/tablet; oral; once per day
Intervention Type
Drug
Intervention Name(s)
Propiverine Hydrochloride
Other Intervention Name(s)
Mictonorm, Propierine Hydrochloride Extended-Release Capsule
Intervention Description
drug of oral capsule
Intervention Type
Drug
Intervention Name(s)
Tolterodine Extended-release Tablet
Intervention Description
4mg/tablet; oral; once per day
Primary Outcome Measure Information:
Title
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record
Description
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
Time Frame
prior to medication and 8 weeks after medication
Secondary Outcome Measure Information:
Title
The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record
Description
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.
Time Frame
prior to medication, 2 weeks and 8 weeks after medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Li, PhD
Organizational Affiliation
Lee's Pharmaceutical
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
We'll reach out to this number within 24 hrs