The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.
This is a Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of AV608 in subjects with idiopathic detrusor overactivity. Female subjects between 18 and 65 years of age with a diagnosis of Overactive Bladder Syndrome and urodynamic observation of involuntary detrusor contractions during the filling phase will be eligible for the trial. Eligible subjects will complete a baseline urodynamic assessment. All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo. At the end of the treatment period, subjects will complete a second urodynamic assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Unnamed facility
Amsterdam, Netherlands
Unnamed facility
Nieuwegein, Netherlands
Unnamed facility
Zeist, Netherlands
Unnamed facility
Birmingham, England, United Kingdom
Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity
Delay of the first involuntary detrusor contraction associated with symptomatic urgency
Urgency, frequency and urge incontinence events as recorded in the Subject Micturition Diary
Urgency Perception Scale
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Unnamed facility
Blackburn, England, United Kingdom
Unnamed facility
Chertsey, England, United Kingdom
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Hull, England, United Kingdom
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Leeds, England, United Kingdom
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Liverpool, England, United Kingdom
Unnamed facility
London, England, United Kingdom
...and 3 more locations