The primary objective of the study was 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 LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Secondary objectives were: * 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), * To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day. The study consisted of 2 periods: * a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then, * a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.
Patients who met the study entry criteria were randomized (2:1:2:1) to one of the 4 dosage groups (Alfuzosin 0.1 mg/kg/day, matching placebo 0.1 mg/kg/day, Alfuzosin 0.2 mg/mg/kg, matching placebo 0.2 mg/kg/day). Patients received their treatment using either solution or tablet formulation depending on age as follows: * Solution to children 2-7 years of age or, children and adolescents 8-16 years of age if they were unable to swallow tablets or they preferred to take the solution or if they had a body weight \< 30kg. The daily dose was devided in 3 doses given at at breakfast, lunch and dinner. * Tablet to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30kg. The daily dose was devided in 2 doses given at at breakfast and dinner. Patients who have completed the 12-week double-blind phase were offered to continue in the 40-week open-label extension study. * Patients receiving Alfuzosin continued with their dosing regimen. * Patients receiving Placebo were switched to Alfuzosin with a dose corresponding to their randomization dose group. All patients had a one-week follow-up period after last dose intake.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Mumbai, India
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-Aventis Administrative Office
Makati City, Philippines
Sanofi-Aventis Administrative Office
Warsaw, Poland
...and 8 more locations
Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O
Detrusor Leak Point Pressure (LPP) was measured by cystometry. For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained. Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment. The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion).
Time frame: 12 weeks (double blind treatment period)
Detrusor Leak Point Pressure (LPP)
Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.
Time frame: baseline and 12 weeks (double blind treatment period)
Absolute Change in Detrusor LPP
Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline
Time frame: 12 weeks ((double blind treatment period)
Relative Change in Detrusor LPP
Relative change = 100 \* (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline
Time frame: 12 weeks (double blind treatment period)
Detrusor Compliance
Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure. It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet).
Time frame: baseline and 12 weeks (double blind treatment period)
Relative Change in Detrusor Compliance
Relative change = 100 \* (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline
Time frame: 12 weeks (double blind treatment period)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture. A symptomatic UTI was defined as the presence of symptoms and a positive culture with \> 100 000 Colony Forming Units (CFUs) with a single organism.
Time frame: 12 weeks (double blind treatment period)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.
Time frame: 52 weeks (double blind treatment period + open label extension treatment period)
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