Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00008822
Trial Description
Title
Study of OnabotulinumtoxinA for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of
urinary incontinence due to neurogenic detrusor overactivity in pediatric patients between
the ages of 8 to 17 years.
Brief Summary in Scientific Language
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Description IPD sharing plan:
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Organizational Data
- DRKS00008822
- 2015/08/11
- 2013/05/09
- no
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Secondary IDs
- 2012-004877-26
- NCT01852045 (ClinicalTrials.gov)
- 191622-120 (Allergan)
- 2012-004877-26
Health Condition or Problem studied
- Urinary Incontinence
- R32 - Unspecified urinary incontinence
Interventions/Observational Groups
- Biological: OnabotulinumtoxinA
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, caregiver, investigator/therapist, assessor
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- Treatment
- Parallel
- III
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Primary Outcome
- Change from Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes; time frame: Baseline, 6 Weeks
Secondary Outcome
- Change from Baseline in Maximum Cystometric Capacity (MCC); time frame: Baseline, Week 6
- Percentage of Patients With Involuntary Detrusor Contractions (IDC); time frame: Week 6
- Change from Baseline in Maximum Detrusor Pressure During the First IDC; time frame: Baseline, Week 6
- Change from Baseline in Detrusor Leak Point Pressure (DLPP); time frame: Baseline, Week 6
- Change from Baseline in Average Urine Volume at First Morning Catheterization; time frame: Baseline, 6 Weeks
- Percentage of Patients With Night Time Urinary Incontinence; time frame: 6 Weeks
- Change from Baseline in Maximum Detrusor Pressure; time frame: Baseline, Week 6
- Time to Patient Request for Retreatment; time frame: 48 Weeks
- Time to Patient Qualification for Retreatment; time frame: 48 Weeks
Countries of Recruitment
- United States
- Austria
- Belgium
- Canada
- Czech Republic
- France
- Germany
- Italy
- Poland
- Turkey
Locations of Recruitment
Recruitment
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- 2013/06/30
- 132
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 8 Years
- 17 Years
Additional Inclusion Criteria
- Urinary incontinence due to neurogenic detrusor overactivity
- Regularly using clean intermittent catheterization to empty the bladder
Exclusion Criteria
- Surgery of the spinal cord within 6 months
- 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
Addresses
-
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- Allergan
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- Allergan
- Medical Director
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- Allergan Inc.
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- clinicaltrials at allergan.com
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Sources of Monetary or Material Support
-
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
- 3
- 2016/01/14
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