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NCT01852045 · ClinicalTrials.gov registry record · Phase 3
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
NCT01852045: Completed Phase 3 study, sponsored by Allergan.
NCT01852045 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 114 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01852045, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
Study 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.
Primary Outcome
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares esti
Interventions
- BIOLOGICAL OnabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2013-07-02 |
| Est. Completion | 2018-10-11 |
| Phase | Phase 3 |
What the finished NCT01852045 record still lists
NCT01852045 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA is the first listed.
NCT01852045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01852045 about?
NCT01852045 is a clinical study titled "Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients". 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.
What is the current status of trial NCT01852045?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2013-07-02. Estimated completion is 2018-10-11.
What interventions are being tested in trial NCT01852045?
The interventions under investigation include: OnabotulinumtoxinA (BIOLOGICAL).
Who is sponsoring clinical trial NCT01852045?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01852045's enrollment target sits among peer trials
114 1648th of 2000 higher than 350 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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