Children with voiding dysfunction of neuropathic etiology MedDRA version: 9.1 Level: LLT Classification code 10047685 Term: Voiding difficulty
Conditions
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children and adolescents of either gender 2 - 16 years of age with a detrusor LPP of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis grade 1 or 2 (Society of Fetal Urology) due to neuropathic bladder dysfunction. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Hydronephrosis of non-neuropathic etiology -Patients who had an urological surgery within the last 4 months prior to the study -Patients who have undergone urethral dilatation within the last 3 months prior to the study -Patients who have received a-blocker therapy within the last 4 weeks prior to the study -Patients who have received any detrusor injections of botulinum toxin in the last six months -Patients with urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper tract dilatation (e.g., bladder anomalies, ureterocele) -Patients with a history of severe respiratory, cardiovascular, gastrointestinal, metabolic, hepatic, neurologic, endocrine, or renal disease or other serious disorders, which would interfere with the interpretation of the study results (e.g.high grade of vesicoureteral reflux) -Patients or parents/legally authorized representatives who are illiterate or are judged to be unable to understand the nature, scope and possible consequences of the study -History of known intolerance to a-blocker therapy -History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome) -QTcF > 450 msec at screening electrocardiogram -History of unexplained loss of consciousness -Orthostatic hypotension -Patients who have taken potent cytochrome P450-3A4 inhibitors in the last 4 weeks prior to the study -Pregnant or breast-feeding females and females of childbearing potential not protected by effective contraceptive methods of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy of alfuzosin in the treatment of children and adolescents 2 - 16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor LPP of neuropathic etiology.;Secondary Objective: -To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents; -To investigate the number of UTI episodes; -To investigate the pharmacokinetics (population kinetics).;Primary end point(s): Change in grade of hydronephrosis. | — |
Countries
Bulgaria, Estonia, Poland, Slovakia, Spain
Outcome results
None listed