Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity (NCT00335660) | Clinical Trial Compass
TerminatedPhase 2
Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
Stopped: Animal Safety Data
Netherlands, United Kingdom62 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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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 (exc…
What they're measuring
1
Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity