A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
NCT ID: NCT00876447
Last Updated: 2019-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
397 participants
INTERVENTIONAL
2009-01-01
2013-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Interventions
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Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor \> 12 weeks as needed for up to 3 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient completed at least 52 weeks in the preceding study.
* No longer than 6 months has elapsed since completion of the preceding study
* Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.
Exclusion Criteria
* Previous or current diagnosis of bladder or prostate cancer.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Middlebury, Connecticut, United States
Randwick, , Australia
Innsbruck, , Austria
Ghent, , Belgium
Rio de Janeiro, , Brazil
Victoria, British Columbia, Canada
Ostrava, , Czechia
Salouël, , France
Kiel, , Germany
Florence, , Italy
Amsterdam, , Netherlands
Epsom, , New Zealand
Poznan, , Poland
Porto, , Portugal
Moscow, , Russia
Singapore, , Singapore
Prešov, , Slovakia
Pretoria, , South Africa
Santa Cruz de Tenerife, , Spain
Hualien City, , Taiwan
Kiev, , Ukraine
London, , United Kingdom
Countries
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References
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Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.
Other Identifiers
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191622-094
Identifier Type: -
Identifier Source: org_study_id
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