Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinence. A randomised, double-blind, placebo-controlled, parallel grouped multicentre clinical trial.
- Conditions
- children suffering from overactive bladder and urinary incontinence
- Registration Number
- EUCTR2004-001243-30-CZ
- Lead Sponsor
- Apogepha Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 490
- male and female Caucasian children aged 6 – 10 years
- suffering from overactive bladder
- who voluntarily signed informed consent and who have parental consent
- body weight between 17 – 45 kg
- micturition frequency of at least 8 micturitions / day
- incontinence episodes (at least 1 within 7 days)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- bladder capacity in ml equal/more than (age+1) x 30 ml
- post void residual urine > 10 ml
- treatment of overactive bladder in the past 28 days
- urinary tract infection
- enuresis nocturna
- dysfunctional voiding and detrusor-sphincter-dyssynergy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate superiority of efficacy of Propiverine hydrochloride compared to placebo in children suffering from overactive bladder with urinary incontinence in terms of micturition frequency per day;Secondary Objective: Efficacy and safety;Primary end point(s): micturition frequency per day
- Secondary Outcome Measures
Name Time Method