NCT00549939|CompletedPhase 3ResultsDMC

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

ALFACHIN

12-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy, Pharmacodynamic and Safety of 2 Doses of Alfuzosin (0.1 mg/kg/Day, 0.2 mg/kg/Day) in the Treatment of Children and Adolescents 2-16 Years With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC57222004-002397-38

Study Type

interventional

Target

172

Locations

17 countries

Sites

Timeline

RegisteredOct 2007

StartedOct 2007

CompletionDec 2009

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

172

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2007

Geographic Reach

17 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

October 1, 2007

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

February 8, 2011

Completed

Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

October 25, 2007

Results QC Date

January 13, 2011

Last Update Submit

October 21, 2014

Conditions

Neurogenic Urinary Bladder

Keywords

childbladderneuropathicalpha blockers

Outcome Measures

Primary Outcomes (1)

Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O
Detrusor Leak Point Pressure (LPP) was measured by cystometry. For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained. Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment. The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion).
12 weeks (double blind treatment period)

Secondary Outcomes (7)

Detrusor Leak Point Pressure (LPP)
baseline and 12 weeks (double blind treatment period)
Absolute Change in Detrusor LPP
12 weeks ((double blind treatment period)
Relative Change in Detrusor LPP
12 weeks (double blind treatment period)
Detrusor Compliance
baseline and 12 weeks (double blind treatment period)
Relative Change in Detrusor Compliance
12 weeks (double blind treatment period)
+2 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Alfuzosin 0.1 mg/kg/day

EXPERIMENTAL

Drug: Alfuzosin

Alfuzosin 0.2 mg/kg/day

EXPERIMENTAL

Drug: Alfuzosin

Interventions

AlfuzosinDRUG

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

Also known as: SL770499

Alfuzosin 0.1 mg/kg/dayAlfuzosin 0.2 mg/kg/day

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age2 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Patient with elevated detrusor Leak Point Pressure (LPP) of neuropathic etiology and Detrusor LPP ≥ 40 cm H2O and \< 100 cm H2O.

You may not qualify if:

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.

Contact the study team to confirm eligibility.