Trials / Completed
CompletedNCT01852045
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OnabotulinumtoxinA | OnabotulinumtoxinA injected into the detrusor wall on Day 1. |
Timeline
- Start date
- 2013-07-02
- Primary completion
- 2018-10-11
- Completion
- 2018-10-11
- First posted
- 2013-05-13
- Last updated
- 2019-11-21
- Results posted
- 2019-10-30
Locations
31 sites across 8 countries: United States, Belgium, Canada, Czechia, France, Italy, Poland, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01852045. Inclusion in this directory is not an endorsement.