NCT00575016

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
BIOLOGICAL	Normal saline (Placebo); botulinum toxin Type A (200U)	Placebo injection on Day 1 and botulinum toxin Type A injection 200 U \> Week 12; injection into the detrusor
BIOLOGICAL	botulinum toxin Type A (50U); botulinum toxin Type A (200U)	botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor
BIOLOGICAL	botulinum toxin Type A (100U); botulinum toxin Type A (200U)	botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor
BIOLOGICAL	botulinum toxin Type A (200U)	botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-02-01
• Completion: 2010-07-01
• First posted: 2007-12-17
• Last updated: 2015-10-02
• Results posted: 2011-10-17

Locations

6 sites across 6 countries: Egypt, Greece, India, Lebanon, Serbia, Turkey (Türkiye)