Neurogenic Urinary Bladder Clinical Trial
Official title:
12-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy, Pharmacodynamic and Safety of 2 Doses of Alfuzosin (0.1 mg/kg/Day, 0.2 mg/kg/Day) in the Treatment of Children and Adolescents 2-16 Years With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01598103 -
Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions
|
Phase 2 |