NCT00439140

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Detailed description

Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
BIOLOGICAL	botulinum toxin Type A	Botulinum toxin Type A injection into the detrusor.
DRUG	Normal Saline (Placebo)	Placebo (Normal Saline) injection into the detrusor.

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2007-02-23
• Last updated: 2014-01-24
• Results posted: 2014-01-24

Locations

4 sites across 4 countries: United States, Australia, Canada, India