Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinenceA randomised, double-blind, placebo-controlled, parallel grouped, multicentre clinical trial
- Conditions
- Overactive bladder with incontinence episodesMedDRA version: 8.0Level: LLTClassification code 10059617
- Registration Number
- EUCTR2004-001243-30-AT
- Lead Sponsor
- APOGEPHA Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
-caucasian
-aged 5-10 years
-signed informed consent and parental consent
-body weight 17-45kg
>= 8 micturitions per day at least in 1 of 3 days
>= 1 incontinence episode in 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 [ml] >= 30(age+1)
-> 10ml post void residual urine
-treatment of overactive bladder symptoms in the last 28 days
-Urinary Tract Infection and other acute and parasitic infections of the genitourinary tract
-enuresis nocturna
-dysfunctional voiding and detrusor-sphincter-dyssynergy
-constipation
-clinical relevant diseases of the kidneys, liver, gastrointestinal tract, cardiovascular system, metabolism
-congenital anomalies of the genitourinary tract
-pre-existing medical contraindications for anticholinergics
-inability of the subject's legally authorised representative or the patient to communicate with the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to demonstrate superior efficacy of Propiverine hydrochloride to Placebo in terms of micturition frequency/24 hours;Secondary Objective: to compare efficacy and safety of Propiverine hydrochloride to placebo in children suffering from overactive bladder and urinary incontinence;Primary end point(s): change in micturition frequency per 24 hours
- Secondary Outcome Measures
Name Time Method