Phase 3
N=25
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Hydronephrosis · Neurogenic Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00576823 ↗Enrolled (actual)
25
Serious AEs
16.0%
Results posted
Feb 2011
Primary outcome: Primary: Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis — 2; 5; 3; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Alfuzosin (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis |
2; 5; 3; 1; 3; 1 | — |
| SECONDARY Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes |
8; 5; 5; 2; 0; 2 | — |
| SECONDARY Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes |
8; 5; 5; 2; 0; 2 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00576823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.