Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Sponsor

Avera Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00335660

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Syndrome	Drug: AV608	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Amsterdam		Netherlands
2	Nieuwegein		Netherlands
3	Zeist		Netherlands
4	Birmingham	England	United Kingdom
5	Blackburn	England	United Kingdom
6	Chertsey	England	United Kingdom
7	Hull	England	United Kingdom
8	Leeds	England	United Kingdom
9	Liverpool	England	United Kingdom
10	London	England	United Kingdom
11	Plymouth	England	United Kingdom
12	Sheffield	England	United Kingdom
13	Falkirk	Scotland	United Kingdom