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

APOGEPHA Arzneimittel GmbH30 enrolled

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.

Study Type

INTERVENTIONAL

Masking

NONE

Enrollment

Conditions

Overactive Bladder

Interventions

propiverine hydrochlorideDRUG

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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