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

Tracking Information

First Received Date ^ICMJE

December 13, 2007

Last Updated Date

June 10, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of episodes of urinary incontinence [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Number of episodes of urinary incontinence

Change History

Complete list of historical versions of study NCT00575016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maximum cystometric capacity (urodynamics) [ Time Frame: Weeks 6 - 24 ] [ Designated as safety issue: No ]
Peak detrusor pressure (urodynamics) [ Time Frame: Weeks 6 - 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Urodynamic parameters

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Overactive Bladder

Intervention ^ICMJE

Biological: placebo/botulinum toxin Type A
Biological: botulinum toxin Type A
Biological: Botulinum toxin Type A

Study Arms / Comparison Groups

Other: Placebo followed by experimental

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Urinary tract infection at time of enrollment

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Egypt, Greece, India, Lebanon, Serbia, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00575016

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

191622-518

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP