This study is designed to demonstrate superiority of efficacy of Propiverine hydrochloride compared to placebo in children suffering from overactive bladder with urinary incontinence.The primary objective is to compare efficacy of Propiverine…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy criteria:
Micturition frequency/24 hours determined per diary documented by parents and
child before and at the end of treatment.
Secondary outcome
Secondary efficacy criteria:
- Occurrence of incontinence episodes/ 7 days determined by questioning
- Number of incontinence episodes / 3 days determined by bladder diary
(parents-child-diary)
- Average voided volume/micturition determined per diary documented by parents
and child before and at the end of treatment
- Course of maximum voiding capacity determined per weekly micturition protocol
documented by child
Evaluation of efficacy by patient, parents and investigator
Background summary
For more than 20 years urinary incontinence as well as urgency and frequency
has been treated with Propiverine hydrochloride. Since 1985 Apogepha offers for
the special patient population of children Mictonetten, a particular dosage
form with 5 mg Propiverine hydrochloride.
This enables the prescribing consultant an individual and appropriate dose for
children.
A clinical trial in conformity with ICH-GCP showing the same high efficacy and
safety as experiences in years of practice have shown, is missing until today.
Therefore the present study was designed and will be performed.
Study objective
This study is designed to demonstrate superiority of efficacy of Propiverine
hydrochloride compared to placebo in children suffering from overactive bladder
with urinary incontinence.
The primary objective is to compare efficacy of Propiverine hydrochloride to
placebo in children suffering from overactive bladder with urinary incontinence
in terms of micturition frequency per day.
The secondary objective is to compare efficacy and safety of Propiverine
hydrochloride to placebo in children suffering from overactive bladder with
urinary incontinence.
Study design
A double-blind, randomised, placebo controlled, parallel grouped, multicentre
clinical trial
with 21 days run-in period, 8 weeks of treatment,
Intervention
The test drug are Mictonetten® , a coated tablet containing 5 mg Propiverine
hydrochloride
Assignment to treatment group depends on body weight.
a) 17.0 - 27.9 kg body weight
10 mg (b.i.d.) Propiverine hydrochloride (2 x 5 mg b.i.d. Mictonetten®)
p.o. or corresponding placebo
b) 28.0 - 45.0 kg body weight
15 mg (b.i.d.) Propiverine hydrochloride (3 x 5 mg b.i.d. Mictonetten®)
p.o. or corresponding placebo ratio of verum to placebo 1 : 1
Study burden and risks
The burden for the patient is minimal and equals the standard procedure and
treatment in patients with an overactive baldder. (except for the ecg)
Children, together with the parents, have to visit the hospital four times.
A burden list is mentioned in the protocol on page 5 and the patient
information sheet.
Kyffhaeuser Strasse 27
01309 Dresden
DE
Kyffhaeuser Strasse 27
01309 Dresden
DE
Listed location countries
Age
Inclusion criteria
Male or female, caucasian children: 5 to 10.
Signed ICD
Body weight of 17-45 kg
Micturation frequency >= 8/day at least in 1 of 3 bladder diary days.
Incontinence episodes (at least 1 within 7 days)
Exclusion criteria
Bladder capacity [ml] >= ((age +1) x 30) [ml]
Post void residual > 10 ml
Treatment of overactive bladder symptoms in the last 28 days
Urinary tract infection at the time of study inclusion and other acute and parasitic infections of the genitourinary tract
Enuresis nocturna
Dysfunctional voiding and detrusor-sphincter-dyssynergy
Constipation
Forbidden concomitant medication (see chapter 9.4.7 of the protocol)
Clinical relevant disease of the kidney, liver, gastro-intestinal tract, cardiovascular system metabolism disorder (e.g. juvenile diabetes mellitus, diabetes insipidus
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2004-001243-30-NL |
| CCMO | NL11578.042.06 |