Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00549939

Purpose

The primary objective of the study is to evaluate the efficacy of alfuzosin in comparison to placebo on the detrusor leak point pressure (LPP) in children with elevated detrusor leak point pressure of neuropathic etiology and detrusor LPP≥ 40 cm H2O. Secondary objectives are to investigate the safety and the pharmacokinetics of two doses of alfuzosin in children and adolescents. The 12 week double blind study phase is followed by a 40-week open label extension with alfuzosin (patients on placebo in the double-blind phase are switched to alfuzosin).

Condition	Intervention	Phase
Neurogenic Urinary Bladder	Drug: alfuzosin (SL770499) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	12-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy, Pharmacodynamic and Safety of 2 Doses of Alfuzosin 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

Resource links provided by NLM:

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Detrusor leak point pressure (LPP) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in detrusor LPP and relative change in detrusor compliance [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Number of documented urinary tract infections [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics of alfuzosin [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Safety of alfuzosin [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dose level 1	Drug: alfuzosin (SL770499) oral solution or tablets depending on the age group
2: Experimental dose level 2	Drug: alfuzosin (SL770499) oral solution or tablets depending on the age group
3: Placebo Comparator	Drug: Placebo oral solution or tablets depending on the age group

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with elevated detrusor LPP of neuropathic etiology

Exclusion Criteria:

Patients who had an urological surgery in the last 4 months prior to the study
Patients who have undergone urethral dilatation in the last 3 months prior to the baseline urodynamic assessment
Patients who have received α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment
Patients who have received any detrusor injections of botulinum toxin in the last 6 months
Patients with 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549939

Show 18 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD study director )
Study ID Numbers:	EFC5722, EUDRACT : 2004-002397-38
Study First Received:	October 25, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00549939 History of Changes
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health; Serbia: Ethics Committee

Keywords provided by Sanofi-Aventis:

child
bladder
neuropathic
alpha blockers

Study placed in the following topic categories:

Urinary Bladder, Neurogenic
Neurotransmitter Agents
Cystocele
Adrenergic Agents
Urinary Bladder Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents

Antihypertensive Agents
Signs and Symptoms
Alfuzosin
Urologic Diseases
Neurologic Manifestations
Adrenergic Antagonists

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Urinary Bladder Diseases
Cardiovascular Agents
Adrenergic alpha-Antagonists

Antihypertensive Agents
Pharmacologic Actions
Signs and Symptoms
Alfuzosin
Urologic Diseases
Therapeutic Uses
Neurologic Manifestations
Adrenergic Antagonists

ClinicalTrials.gov processed this record on September 10, 2009