Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder

Sponsor

APOGEPHA Arzneimittel GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00795925

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: propiverine hydrochloride	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Masking:

None (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)

Study Start Date :

Oct 1, 2004

Actual Study Completion Date :

Dec 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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. []

Secondary Outcome Measures

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. [two weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Main Inclusion Criteria:

Micturition Frequency ≥6 micturitions during awake period
Urge Incontinence Episodes ≥1/week
Urgency Episodes ≥1/day

Main Exclusion Criteria:

Contraindication to anticholinergic therapy
Repeated measurement of Post Void Residual ≥20 mL
Nocturnal Enuresis
Clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus
Anatomical abnormalities of the urinary tract