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Tracking Information | |
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First Received Date † | February 20, 2009 |
Last Updated Date | February 24, 2009 |
Start Date † | August 2008 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00850733 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | 516-BOTOX Urinary Incontinence Detrusor |
Official Title † | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Safety and Efficacy of a Single Treatment With 2 Dose Levels of BOTOX Purified Neurotoxin Complex Followed by a Treatment With BOTOX in Patients With… |
Brief Summary | The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy. |
Detailed Description | |
Study Phase | |
Study Type † | Observational |
Study Design † | |
Condition † |
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Intervention † | |
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Not yet recruiting |
Enrollment † | |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 80 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00850733 |
Responsible Party | Michael Albo, MD, Veterans Medical Research Foundation |
Secondary IDs †† | VMRF Project #07366 |
Study Sponsor † | Veterans Medical Research Foundation |
Collaborators †† | Allergan |
Investigators † | |
Information Provided By | Veterans Medical Research Foundation |
Verification Date | February 2009 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |