A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 13
- 主要终点
- Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity
研究概览
简要总结
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity
次要结局
- 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