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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 2010
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.
- 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
- 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
- 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
- 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
- Lead Sponsor
- Lee’s Pharmaceutical Limited
- APOGEPHA Arzneimittel GmbH
- Provider of Information About this Clinical Study
- Overall Official(s)
- Benjamin Li, PhD, Study Director, Lee’s Pharmaceutical
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