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

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ClinicalTrials.gov Identifier: NCT00795925
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : November 21, 2008
Sponsor:
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

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 ]


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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008

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
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Propiverine
Parasympatholytics
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