Overactive Bladder Syndrome
Conditions
Keywords
Idiopathic Detrusor Overactivity, NK-1 Receptor Antagonist, Neurokinin, Urge Incontinence
Brief summary
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.
Detailed description
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.
Interventions
DRUGAV608
Sponsors
Avera Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female, 18 to 65 years of age, inclusive * A current primary diagnosis of OAB * Idiopathic detrusor overactivity, demonstrated by a urodynamic observation * Evidence of frequency in combination with urinary urgency * Written informed consent form * Willingness to avoid pregnancy and practice adequate birth control * Negative serum pregnancy test * Agrees to refrain from blood donation during the course of the study
Exclusion criteria
* Subjects who are pregnant or lactating * Clinically significant abnormality or clinically significant unstable medical condition * QTc interval of 470 msec or greater at Visit 1 * Predominant stress urinary incontinence versus urge urinary incontinence based on subject history * Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis, etc.) * Anatomic or structural abnormalities possibly causing urinary incontinence or urgency, including but not limited to urogenital prolapse stage 2 or more according to the Pelvic Organ Prolapse Quantification (POP-Q) system * Urological or gynecological surgery within 3 months of the baseline urodynamic assessment * Current UTI or frequent UTIs (i.e., greater than or equal to 4 UTIs per year), interstitial cystitis, hematuria of unknown cause, or use of indwelling catheter * Electro-stimulation therapy, bladder training, or physiotherapy for bladder control within 2 weeks of Visit 1 * History (within 1 year of Screening) of alcohol or substance dependence (except nicotine dependence) according to DSM-IV-TR criteria * History of any kind of cancer within the last 2 years * Existing non-malignant tumors that could compromise the function and/or anatomy of the lower urinary tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed