Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinenceA randomised, double-blind, placebo-controlled, parallel grouped, multicentre clinical trial

Phase 1

• Conditions: children suffering from overactive bladder and urinary incontinence; MedDRA version: 8.0Level: lltClassification code 10059617

• Registration Number: EUCTR2004-001243-30-NL
• Lead Sponsor: APOGEPHA Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-16
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Female and male, Caucasian children aged: 5-10 years
- Signed informed consent and parental consent
- Body weight of 17-45 kg
- Micturition frequency >= 8/day at least in 1 of 3 diary days
- 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

Exclusion Criteria

- Bladder capacity in [ml] >= (age+1)x30 [ml]
- Post void residual urine > 10 ml
- Treatment of overactive bladder symptoms in the last 28 days
- Urinary tract infection at the time of study inclusion or other acute and parasitic infections of the genitourinary tract
- Enuresis nocturna
- Dysfunctional voiding and detrusor-sphincter-dyssynergy
- Constipation
- Forbidden concomitant medication
- Clinical relevant disease of the kidneys, liver, gastrointestinal tract, cardiovascular system, metabolism
- Congenital anomalies of the genitourinary tract
- 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
Primary end point(s): Micturition frequency/24h;Main Objective: The study objective is to demonstrate the superior efficacy of Propiverine hydrochloride to placebo in terms of micturition frequency/24 hours in children with overactive bladder in a large scale multicentre clinical study meeting ICH-GCP and regulatory requirements;Secondary Objective: The secondary objective is to compare efficacy and safety of Propiverine hydrochloride to placebo in children suffering from overactive bladder with urinary inontinence