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

Sponsored by:	APOGEPHA Arzneimittel GmbH
Information provided by:	APOGEPHA Arzneimittel GmbH
ClinicalTrials.gov Identifier:	NCT00795925

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 II

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Mictonorm Propiverine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Pharmacokinetics Study
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)

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
propiverine hydrochloride: Experimental	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

Study ID Numbers:	APOGEPHA-8403030
Study First Received:	November 13, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795925
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

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Propiverine
Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence

Additional relevant MeSH terms:

Parasympatholytics
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists

Autonomic Agents
Physiological Effects of Drugs
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009