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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propiverine hydrochloride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propiverine hydrochloride | Drug | coated tablets containing 5 mg consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor Ulla Sillen, M.D. | Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20384395 | Derived | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C015586 | propiverine |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |