A Phase 3 interventional study of Propiverine Hydrochloride and Tolterodine Extended-release Tablet in Overactive Bladder, sponsored by Lee's Pharmaceutical Limited. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-01-25.
Sponsored by Lee's Pharmaceutical Limited · Phase 3, Interventional, and Treatment
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.
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 324 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Lee's Pharmaceutical Limited is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 mg/capsule; oral; once per day
Drug: Propiverine Hydrochloride
4mg/tablet; oral; once per day
Drug: Tolterodine Extended-release Tablet
drug of oral capsule
Also known as: Mictonorm, Propierine Hydrochloride Extended-Release Capsule
4mg/tablet; oral; once per day
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
Time frame: 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
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
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Lee's Pharmaceutical Limited