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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: APOGEPHA Arzneimittel GmbH
• Treatments: Propiverine

Criteria

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