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
|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|
|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.
- 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.
- 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 ]
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
|Principal Investigator:||Professor Ulla Sillen, M.D.||Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg|