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NCT00311376 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 416
- Enrollment target
NCT00311376: Completed Phase 3 study, sponsored by Allergan.
NCT00311376 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 416 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00311376, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 416 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
Primary Outcome
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Interventions
- BIOLOGICAL botulinum toxin Type A (200U)
- BIOLOGICAL botulinum toxin Type A (300U)
- OTHER Normal Saline (Placebo); botulinum toxin Type A (200U)
- OTHER Normal Saline (Placebo); botulinum toxin Type A (300U)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT00311376 record still lists
NCT00311376 is an interventional study that assigns participants to a tested intervention. The registered 416 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 (46% lower).
The record links to 0 conditions, and to 4 interventions - of which botulinum toxin Type A (200U) is the first listed.
NCT00311376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00311376 about?
NCT00311376 is a clinical study titled "Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder". The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
What is the current status of trial NCT00311376?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2006-08. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00311376?
The interventions under investigation include: botulinum toxin Type A (200U) (BIOLOGICAL), botulinum toxin Type A (300U) (BIOLOGICAL), Normal Saline (Placebo); botulinum toxin Type A (200U) (OTHER), Normal Saline (Placebo); botulinum toxin Type A (300U) (OTHER).
Who is sponsoring clinical trial NCT00311376?
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 NCT00311376's enrollment target sits among peer trials
416 902nd of 2000 higher than 1,098 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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