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

Phase 2

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: propiverine hydrochloride

• Registration Number: NCT00795925
• Lead Sponsor: APOGEPHA Arzneimittel GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-12
• Status Verified: 2008-11
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-20
• Last Update Submitted: 2008-11-20
• Study First Posted: 2008-11-21
• Last Update Posted: 2008-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Main

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
propiverine hydrochloride	propiverine hydrochloride	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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