CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 275 enrolled
Drug / intervention
botulinum toxin Type A (200U) +3 morebiological
Likely dose
Botulinum toxin Type A 200U or 300U injected into the detrusor on Day 1, with repeat injection >Week 12AI-extracted
Key inclusion· 2
  • ✓Urinary incontinence due to neurogenic overactive bladder caused by spinal cord injury or multiple sclerosis
  • ✓Inadequate response to anticholinergic medication for overactive bladder
Key exclusion· 3
  • ✕History or evidence of pelvic or urologic abnormality
  • ✕Previous or current diagnosis of bladder or prostate cancer
  • ✕Urinary tract infection at time of enrollment

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

Search/NCT00461292
NCT00461292Phase 3Completed
CompareCT.gov

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

Allergan·interventional·Posted Apr 17, 2007·Updated Oct 2, 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 275 participants across 12 sites in 12 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
CountriesBrazil, Canada, France, Italy, Netherlands, Portugal, Singapore, South Africa, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2007
Enrollment StartMay 1, 2007
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.2 years ago

Interventions

botulinum toxin Type A (200U)biological

botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection \> Week 12; injections into detrusor

botulinum toxin Type A (300U)biological

botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor

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

Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection \> 12 weeks; injections into detrusor

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

Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor