Phase 3 N=172 Randomized Quadruple-blind Treatment

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

Neurogenic Urinary Bladder

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View on ClinicalTrials.gov: NCT00549939 ↗

Enrolled (actual)

172

Serious AEs

10.1%

Results posted

Feb 2011

Primary outcome: Primary: Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O — 23; 23; 28; 34 participants — p=1.00

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Alfuzosin (Drug); Placebo (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Sanofi
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O	23; 23; 28; 34; 34; 30	1.00
SECONDARY Detrusor Leak Point Pressure (LPP)	54.2; 53.3; 50.9; 48.2; 41.6; 39.4	—
SECONDARY Absolute Change in Detrusor LPP	-5.4; -11.7; -12.5	0.1040
SECONDARY Relative Change in Detrusor LPP	-9.2; -20.6; -23.5	0.1338
SECONDARY Detrusor Compliance	3.4; 3.4; 3.3; 4.8; 5.3; 5.8	—
SECONDARY Relative Change in Detrusor Compliance	113.6; 126.6; 98.6	0.7889
SECONDARY Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes	66; 70; 12; 13; 3; 0	—
SECONDARY Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes	66; 70; 12; 13; 3; 0	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00549939). 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.