Status:
TERMINATED
Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
Lead Sponsor:
Avera Pharmaceuticals
Conditions:
Overactive Bladder Syndrome
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00335660
Start Date
June 1 2006
End Date
September 1 2007
Last Update
February 25 2008
Active Locations (13)
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1
Amsterdam, Netherlands
2
Nieuwegein, Netherlands
3
Zeist, Netherlands
4
Birmingham, England, United Kingdom