Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Avera Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Overactive Bladder Syndrome

Treatments

Drug: AV608

Study type

Interventional

Funder types

Industry

Identifiers

NCT00335660

AV608-106

Details and patient eligibility

About

The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.

Full 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.

Enrollment

62 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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