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Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

NCT00549939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2014-10-29

Study results available
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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.

Conditions

  • Neurogenic Urinary Bladder

Interventions

DRUG

Alfuzosin

Form: solution or tablet according to age Route: oral Dose: daily dose adjusted to body weight

DRUG

Placebo

Form: matching solution or matching tablet according to age Route: oral Dose: daily dose adjusted to body weight

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-03-31
Completion
2009-12-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Estonia
  • France
  • Germany
  • India
  • Malaysia
  • Philippines
  • Poland
  • Portugal
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549939 on ClinicalTrials.gov