Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AV608

Intervention Type DRUG

Eligibility Criteria

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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 (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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No