NCT00461292 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder | Biotech Hunter

Enrollment

275

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

March 31, 2010

Study Completion Date

April 30, 2010

Conditions

Overactive Bladder

Interventions

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

Trial Locations (12)

Middlebury

Rio de Janeiro

Victoria

Salouël

Milan

Amsterdam

Porto

Singapore

Pretoria

Santa Cruz de Tenerife

Hualien City

Scunthorpe