Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Phase 2

Terminated

• Conditions: Overactive Bladder Syndrome

• Registration Number: NCT00335660
• Lead Sponsor: Avera Pharmaceuticals

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Primary Completion: 2007-06
• Study Completion: 2007-09
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-15
• Last Update Posted: 2008-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity

Secondary Outcome Measures

Name	Time	Method
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