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Completed

NCT Number: NCT00795925

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propiverine hydrochloride

Drug

coated tablets containing 5 mg

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

APOGEPHA Arzneimittel GmbH

Industry

Registry information

Official study title

Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)

Important dates

Study start
2004
Study completion
2005
First posted
Nov 21, 2008
Registry last updated
Nov 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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