NCT00461292

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: 275 (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 injection at Day 1 followed by botulinum toxin Type A 200 U injection \> Week 12; injections into detrusor
BIOLOGICAL	botulinum toxin Type A (300U)	botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor
OTHER	Normal saline (Placebo); botulinum toxin Type A (200U)	Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection \> 12 weeks; injections into detrusor
OTHER	Normal saline (Placebo); botulinum toxin Type A (300U)	Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2007-04-17
• Last updated: 2015-10-02
• Results posted: 2011-10-17

Locations

12 sites across 12 countries: United States, Brazil, Canada, France, Italy, Netherlands, Portugal, Singapore, South Africa, Spain, Taiwan, United Kingdom