Overview

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