Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder
The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
|Official Title:||Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)|
- Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups.
- Tolerability of propiverine. Efficacy: Changes from baseline: voiding frequency, incontinence and urgency episodes,voided volume. Safety: Post Void Residual (PVR),adverse events,laboratory values (urine, blood), ECG. [ Time Frame: two weeks ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2005|
|Experimental: propiverine hydrochloride||
Drug: propiverine hydrochloride
coated tablets containing 5 mg
consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.