Who is sponsoring NCT00795925?

NCT00795925 is sponsored by APOGEPHA Arzneimittel GmbH.

What condition does NCT00795925 study?

NCT00795925 studies Overactive Bladder.

What drugs are being tested in NCT00795925?

Interventions: propiverine hydrochloride.

What is the status of NCT00795925?

NCT00795925 is currently COMPLETED.

Last reviewed 2008-11-20 · How we verify

Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)

NCT00795925 Phase 2 COMPLETED

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.

Details

Lead sponsor	APOGEPHA Arzneimittel GmbH
Phase	Phase 2
Status	COMPLETED
Enrolment	30
Start date	2004-10
Completion	2005-12

Conditions

Overactive Bladder

Interventions

propiverine hydrochloride

Primary outcomes

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.