Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
NCT ID: NCT01852045
Last Updated: 2019-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2013-07-02
2018-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OnabotulinumtoxinA 50 U
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
OnabotulinumtoxinA 100 U
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
OnabotulinumtoxinA 200 U
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.
OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Interventions
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OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regularly using clean intermittent catheterization to empty the bladder
Exclusion Criteria
* Diagnosis of cerebral palsy
* Current or planned use of a baclofen pump
* Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
* Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
* Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
* Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
5 Years
17 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Margarita Furmanov
Role: STUDY_DIRECTOR
Allergan
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
William Beaumont Hospital Research Institute
Royal Oak, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Pediatric Urology Associates, PC
Tarrytown, New York, United States
McKay Urology Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Oklahoma Childrens Hospital
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
UZ Antwerpen
Antwerp, , Belgium
UZ Gent , Urology
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
McMaster University Medical Centre
Hamilton, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Hopital Pellegrin - Enfants
Bordeaux, , France
CHU de Limoges - Hopital Mere et l'Enfant
Limoges, , France
Hopital Trousseau
Paris, , France
Necker Enfants Malades Hospital
Paris, , France
Seconda Università di Napoli
Caserta, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed
Gdansk, , Poland
Specjalistyczny Gabinet Lekarski
Poznan, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, , Poland
Ankara University Medical Faculty Cebeci Hospital
Ankara, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.
Other Identifiers
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2012-004877-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
191622-120
Identifier Type: -
Identifier Source: org_study_id
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