CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 548 enrolled
Drug / intervention
onabotulinumtoxinA +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00910520
NCT00910520Phase 3Completed
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Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Allergan·interventional·Posted Jun 1, 2009·Updated Mar 5, 2013

In Brief

A Phase 3 clinical trial evaluating onabotulinumtoxinA and normal saline for Overactive Bladder. Completed, enrolled 548 participants across 7 sites in 7 countries.

Detailed Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesBelgium, Czechia, Germany, Poland, Russia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 1, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.1 years ago

Interventions

onabotulinumtoxinAbiological

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).

normal salinedrug

Normal saline (placebo) injected into the detrusor at Day 1.