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: Interventional
- Study Design
- Masking: None (Open Label)
- 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
- 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.
- 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
- 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
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