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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Masking: None (Open Label)

Interventions

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

Arms, Groups and Cohorts

  • Experimental: propiverine hydrochloride

Clinical Trial Outcome Measures

Primary 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 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.
    • Time Frame: two weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • APOGEPHA Arzneimittel GmbH
  • Overall Official(s)
    • Professor Ulla Sillen, M.D., Principal Investigator, Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.