Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

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

Study Overview

• Status: Terminated
• Conditions: Overactive Bladder Syndrome
• Intervention / Treatment: Drug: AV608

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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
  • Nieuwegein, Netherlands
  • Zeist, Netherlands
• United Kingdom
  • England
    • Birmingham, England, United Kingdom
    • Blackburn, England, United Kingdom
    • Chertsey, England, United Kingdom
    • Hull, England, United Kingdom
    • Leeds, England, United Kingdom
    • Liverpool, England, United Kingdom
    • London, England, United Kingdom
    • Plymouth, England, United Kingdom
    • Sheffield, England, United Kingdom
  • Scotland
    • Falkirk, Scotland, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Avera Pharmaceuticals
• Investigators: Principal Investigator: Linda Cardozo, MD FRCOG, King's College Hospital NHS Trust; Study Director: Joao Siffert, MD, Avera Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: June 8, 2006
• First Submitted That Met QC Criteria: June 9, 2006
• First Posted (Estimate): June 12, 2006

Study Record Updates

• Last Update Posted (Estimate): February 25, 2008
• Last Update Submitted That Met QC Criteria: February 15, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Urge Incontinence; NK-1 Receptor Antagonist; Idiopathic Detrusor Overactivity; Neurokinin
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: AV608-106