CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 enrolled
Drug / intervention
botulinum toxin Type A (200U) +3 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/NCT00311376
NCT00311376Phase 3Completed
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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

Allergan·interventional·Posted Apr 6, 2006·Updated Dec 4, 2015

In Brief

A Phase 3 clinical trial evaluating botulinum toxin Type A (200U), botulinum toxin Type A (300U), and 2 other interventions for Overactive Bladder. Completed, enrolled 416 participants across 14 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, New Zealand, Poland, Russia, Slovakia, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2006
Enrollment StartAug 1, 2006
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.2 years ago

Interventions

botulinum toxin Type A (200U)biological

botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

botulinum toxin Type A (300U)biological

botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at \> 12 weeks interval

Normal Saline (Placebo); botulinum toxin Type A (200U)other

Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

Normal Saline (Placebo); botulinum toxin Type A (300U)other

Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at \> 12 weeks interval