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NCT03320850 · ClinicalTrials.gov registry record · Phase 2
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 383
- Enrollment target
NCT03320850: Completed Phase 2 study, sponsored by Allergan.
NCT03320850 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 383 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03320850, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 383 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Primary Outcome
The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.
Interventions
- DRUG OnabotulinumtoxinA and Hydrogel admixture
- DRUG Placebo and Hydrogel admixture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2017-10-04 |
| Est. Completion | 2020-07-21 |
| Phase | Phase 2 |
What the finished NCT03320850 record still lists
NCT03320850 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 2 interventions - of which OnabotulinumtoxinA and Hydrogel admixture is the first listed.
NCT03320850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03320850 about?
NCT03320850 is a clinical study titled "BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence". This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
What is the current status of trial NCT03320850?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 383 participants. The study started on 2017-10-04. Estimated completion is 2020-07-21.
What interventions are being tested in trial NCT03320850?
The interventions under investigation include: OnabotulinumtoxinA and Hydrogel admixture (DRUG), Placebo and Hydrogel admixture (DRUG).
Who is sponsoring clinical trial NCT03320850?
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 NCT03320850's enrollment target sits among peer trials
383 111th of 2000 higher than 1,890 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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