Clinical trial NCT00335660: Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Overactive Bladder Syndrome
Keywords: Idiopathic Detrusor Overactivity
NK-1 Receptor Antagonist
Neurokinin
Urge Incontinence
Lead sponsor: Avera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-06-12
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity
Secondary outcomes:
measure: Delay of the first involuntary detrusor contraction associated with symptomatic urgency
measure: Urgency, frequency and urge incontinence events as recorded in the Subject Micturition Diary
measure: Urgency Perception Scale
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Zeist
country: Netherlands
city: Birmingham
country: United Kingdom
state: England
city: Blackburn
country: United Kingdom
state: England
city: Chertsey
country: United Kingdom
state: England
city: Hull
country: United Kingdom
state: England
city: Leeds
country: United Kingdom
state: England
city: Liverpool
country: United Kingdom
state: England
city: London
country: United Kingdom
state: England
city: Plymouth
country: United Kingdom
state: England
city: Sheffield
country: United Kingdom
state: England
city: Falkirk
country: United Kingdom
state: Scotland
Study officials:
affiliation: King's College Hospital NHS Trust
name: Linda Cardozo, MD FRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: Avera Pharmaceuticals, Inc.
name: Joao Siffert, MD
role: STUDY_DIRECTOR
References: