Overview

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Alfuzosin
Criteria
Inclusion Criteria:

- Patient with elevated detrusor Leak Point Pressure (LPP) of neuropathic etiology and
Detrusor LPP ≥ 40 cm H2O and < 100 cm H2O.

Exclusion Criteria:

- Urological surgery in the last 4 months prior to the study,

- Patients who have urethral dilatation in the last 3 months prior to the baseline
urodynamic assessment,

- α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment,

- Detrusor injections of botulinum toxin in the last 6 months,

- Urological diseases/conditions other than functional bladder obstruction of
neuropathic etiology that can lead to upper urinary tract dilatation (e.g., bladder
anomalies, ureterocele),

- History of intolerance to α-blocker therapy,

- Orthostatic hypotension,

- History of risk factors for Torsade de pointes (e.g., family history of Long QT
Syndrome).

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.