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

Apogepha

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: propiverine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00795925

APOGEPHA-8403030

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

30 participants in 1 patient group

propiverine hydrochloride

Experimental group

Treatment:

Drug: propiverine hydrochloride