Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
NCT ID: NCT01157377
Last Updated: 2014-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2010-10-31
2013-05-31
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
DOUBLE
Study Groups
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AGN-214868 total dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
AGN-214868
AGN-214868 injected into the bladder.
AGN-214868 total dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
AGN-214868
AGN-214868 injected into the bladder.
AGN-214868 total dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
AGN-214868
AGN-214868 injected into the bladder.
AGN-214868 total dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
AGN-214868
AGN-214868 injected into the bladder.
AGN-214868 total dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
AGN-214868
AGN-214868 injected into the bladder.
AGN-214868 total dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
AGN-214868
AGN-214868 injected into the bladder.
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
AGN-214868 placebo
AGN-214868 placebo injected into the bladder.
Interventions
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AGN-214868
AGN-214868 injected into the bladder.
AGN-214868 placebo
AGN-214868 placebo injected into the bladder.
Eligibility Criteria
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Inclusion Criteria
* If male, must agree to use acceptable contraception
* Symptoms of overactive bladder with urinary urgency incontinence
* Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
Exclusion Criteria
* History of bladder surgery
* Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks
* Previous treatment with botulinum toxin therapy of any serotype for any urological condition
18 Years
75 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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Richmond, Virginia, United States
Lyon, , France
Amsterdam, , Netherlands
Countries
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Other Identifiers
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214868-004
Identifier Type: -
Identifier Source: org_study_id
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