Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.