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

This study has been completed.
Sponsor:
Information provided by:
APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00795925
First received: November 13, 2008
Last updated: November 20, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
 Drug: propiverine hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Official Title: Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by APOGEPHA Arzneimittel GmbH:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: October 2004
Study Completion Date: December 2005
Arms Assigned Interventions
Experimental: propiverine hydrochloride Drug: propiverine hydrochloride

coated tablets containing 5 mg

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

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795925

Sponsors and Collaborators
APOGEPHA Arzneimittel GmbH
Investigators
Principal Investigator: Professor Ulla Sillen, M.D. Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg
  More Information

No publications provided by APOGEPHA Arzneimittel GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00795925     History of Changes
Other Study ID Numbers: APOGEPHA-8403030
Study First Received: November 13, 2008
Last Updated: November 20, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by APOGEPHA Arzneimittel GmbH:
propiverine
anticholinergics
urinary incontinence
 overactive bladder
children
dose-finding in children aged 5-10 years

Additional relevant MeSH terms:
Urinary Incontinence
Stress, Psychological
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Urinary Bladder Diseases
Propiverine
 Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013