Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2004
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 13, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedNovember 21, 2008
November 1, 2008
November 13, 2008
November 20, 2008
Conditions
Keywords
Outcome Measures
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.
two weeks
Study Arms (1)
propiverine hydrochloride
EXPERIMENTALInterventions
coated tablets containing 5 mg consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.
Eligibility Criteria
You may qualify if:
- Micturition Frequency ≥6 micturitions during awake period
- Urge Incontinence Episodes ≥1/week
- Urgency Episodes ≥1/day
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Siegmund W, Sillen U, Lackgren G, Schnabel F, Murtz G, Feustel C. Pharmacokinetics and pharmacodynamics of propiverine in children aged between 5 and 10 years with symptoms of overactive bladder. Clin Pharmacokinet. 2010 May;49(5):335-42. doi: 10.2165/11319990-000000000-00000.
PMID: 20384395DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor Ulla Sillen, M.D.
Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 13, 2008
First Posted
November 21, 2008
Study Start
October 1, 2004
Study Completion
December 1, 2005
Last Updated
November 21, 2008
Record last verified: 2008-11