Status:
COMPLETED
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
Lead Sponsor:
Lee's Pharmaceutical Limited
Collaborating Sponsors:
APOGEPHA Arzneimittel GmbH
Conditions:
Overactive Bladder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 urgen...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT01512004
Start Date
January 1 2010
End Date
August 1 2011
Last Update
January 25 2012
Active Locations (1)
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1
Beijing Chaoyang Hospital
Beijing, China