Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder | NCT00575016 | Trialant
TerminatedInterventionalPhase 2Updated Oct 2, 2015
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
ClinicalTrials.gov ID
NCT00575016
Lead Sponsor
AllerganINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 2
Enrollment
74Actual
Last Update Posted
Oct 2, 2015Estimated
Start Date
Dec 2007
Primary Completion Date
Feb 2010Actual
Completion Date
Jul 2010Actual
Brief 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.
Overactive Bladder
Normal saline (Placebo); botulinum toxin Type A (200U)
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
botulinum toxin Type A (200U)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria:
History or evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer