Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

NCT ID: NCT00549939

Last Updated: 2014-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-12-31

Brief 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.

Detailed Description

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.

Conditions

Neurogenic Urinary Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Form: matching solution or matching tablet according to age

Route: oral

Dose: daily dose adjusted to body weight

Alfuzosin 0.1 mg/kg/day

Group Type: EXPERIMENTAL

Alfuzosin

Intervention Type: DRUG

Form: solution or tablet according to age

Route: oral

Dose: daily dose adjusted to body weight

Alfuzosin 0.2 mg/kg/day

Group Type: EXPERIMENTAL

Alfuzosin

Intervention Type: DRUG

Form: solution or tablet according to age

Route: oral

Dose: daily dose adjusted to body weight

Interventions

Alfuzosin

Form: solution or tablet according to age

Route: oral

Dose: daily dose adjusted to body weight

Intervention Type: DRUG

Placebo

Form: matching solution or matching tablet according to age

Route: oral

Dose: daily dose adjusted to body weight

Intervention Type: DRUG

Other Intervention Names

SL770499

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Sofia, , Bulgaria

Sanofi-Aventis Administrative Office

Laval, , Canada

Sanofi-Aventis Administrative Office

Tallinn, , Estonia

Sanofi-Aventis Administrative Office

Paris, , France

Sanofi-Aventis Administrative Office

Berlin, , Germany

Sanofi-Aventis Administrative Office

Mumbai, , India

Sanofi-Aventis Administrative Office

Kuala Lumpur, , Malaysia

Sanofi-Aventis Administrative Office

Makati City, , Philippines

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

Sanofi-Aventis Aministrative Office

Moscow, , Russia

Sanofi-Aventis Administrative Office

Belgrade, , Serbia

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Sanofi-Aventis Administrative Office

Bratislava, , Slovakia

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Countries

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

Other Identifiers

2004-002397-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC5722

Identifier Type: -

Identifier Source: org_study_id