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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00795925
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : November 21, 2008
Information provided by:
APOGEPHA Arzneimittel GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: propiverine hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Masking: None (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)
Study Start Date : October 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00795925

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00795925     History of Changes
Other Study ID Numbers: APOGEPHA-8403030
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008
Keywords provided by APOGEPHA Arzneimittel GmbH:
urinary incontinence
overactive bladder
dose-finding in children aged 5-10 years
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents