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

Overactive Bladder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795925
• Other study ID #: APOGEPHA-8403030
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2008
• Last updated: November 20, 2008
• Start date: October 2004
• Est. completion date: December 2005

Study information

• Verified date: November 2008
• Source: APOGEPHA Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• propiverine hydrochloride
coated tablets containing 5 mg consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
APOGEPHA Arzneimittel GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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