Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
Condition: Neurogenic Urinary Bladder
MeSH terms: Urinary Bladder, Neurogenic
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Alfuzosin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Form: solution or tablet according to age
Route: oral
Dose: daily dose adjusted to body weight; Form: matching solution or matching tablet according to age
Route: oral
Dose: daily dose adjusted to body weight
Other intervention name(s): SL770499
Intervention MeSH terms: Alfuzosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: child; bladder; neuropathic; alpha blockers