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 elevated detrusor LPP of neuropathic etiology -Detrusor leak point pressure > or = 40 cm H2O 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: -Patients who had an urological surgery in the last 4 months prior to the study -Patients who have undergone urethral dilatation in the last 3 months prior to the baseline urodynamic assessment -Patients who have received a-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment -Patients who have received any detrusor injections of botulinum toxin - Patients with urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper urinary 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 -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 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 (ECG) -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 evaluate the efficacy of alfuzosin in comparison to placebo on the detrusor leak point pressure (LPP) in children and adolescents 2 – 16 years of age with elevated detrusor leak point pressure of neuropathic etiology and detrusor LPP > or = 40 cm H2O;Secondary Objective: -To investigate the safety and tolerability of two doses of alfuzosin in comparison to placebo in children and adolescents -To evaluate the effects of the two doses of alfuzosin in comparison to placebo on : Detrusor compliance Urinary tract infection -To investigate the pharmacokinetics of alfuzosin (population kinetics) after 12 weeks of treatment -To evaluate the 12-month long-term safety of alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day;Primary end point(s): Detrusor leak point pressure (LPP) evaluated at baseline and week 12. | — |
Countries
Bulgaria, Estonia, France, Germany, Poland, Portugal, Slovakia, Spain
Outcome results
None listed