Clinical trial NCT00576823: Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Official title: 12-week, Multicenter, Open-label, Non-comparative Study to Investigate Pharmacodynamic and Safety of Alfuzosin 0.2 mg/kg/Day in the Treatment of Children and Adolescents 2 - 16 Years of Age With Hydronephrosis Associated With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hydronephrosis
Neurogenic Bladder
Keywords: child
bladder
neuropathic
alpha blockers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology.

Secondary objectives were:

* To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents,
* To investigate the number of Urinary Tract Infection (UTI) episodes,
* To investigate the pharmacokinetics of Alfuzosin (population kinetics).

Detailed description: The study consisted of 2 phases:

* a 12-week efficacy phase then,
* a 40-week safety extension phase.

All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets.

Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase.

All patients had a one-week follow-up period after the last dose intake.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

Exclusion Criteria:

* Hydronephrosis of non-neuropathic etiology.
* Urological surgery in the last 4 months prior to the study.
* 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.

Primary outcomes:
measure: Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis
timeFrame: baseline and 12 weeks (efficacy study phase)
Secondary outcomes:
measure: Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
timeFrame: 12 weeks (efficacy study phase)
measure: Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
timeFrame: 52 weeks (efficacy and extension study phases)
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Tallin
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Kuala Lumpur
country: Malaysia
facility: Sanofi-Aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Belgrade
country: Serbia
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Aministrative Office
city: Bratislava
country: Slovakia
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: