NCT00311376

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
BIOLOGICAL	botulinum toxin Type A (200U)	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
BIOLOGICAL	botulinum toxin Type A (300U)	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
OTHER	Normal Saline (Placebo); botulinum toxin Type A (200U)	Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval
OTHER	Normal Saline (Placebo); botulinum toxin Type A (300U)	Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at \> 12 weeks interval

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2006-04-06
• Last updated: 2015-12-04
• Results posted: 2011-10-17

Locations

14 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, New Zealand, Poland, Russia, Slovakia, Ukraine, United Kingdom