NCT00321477已完成2 期
NK1 Receptor Antagonist vs Placebo in the Treatment of Overactive Bladder Symptoms
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 58
- 主要终点
- Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs
研究概览
简要总结
This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with overactive bladder in women.
详细描述
A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in Women with Overactive Bladder
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects with overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.
- •Must not be pregnant.
- •Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- •Body weight in the range of = 45 kg and <100 kg.
排除标准
- •Stage III/IV pelvic organ prolapse with or without cystocele.
- •History of interstitial cystitis or bladder related pain.
- •Subjects with stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.
- •History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening.
- •Subjects with urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence).
- •Nocturnal enuresis only.
- •Urinary retention, or other evidence of poor detrusor function.
- •History of prior anti-incontinence surgery.
- •History of radiation cystitis or a history of pelvic irradiation.
- •Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.
- •Participated in any clinical trial of an investigation drug that may affect urinary function within 3 months of enrollment into the study.
- •Received any investigational product within 30 days of enrollment into the study.
结局指标
主要结局
Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs
时间窗: 12 weeks
次要结局
- Change from baseline to Weeks 6 and 12 in the following endpoints: Number of micturitions/24 hrs Number of urgency episodes/24 hrs Number of nocturia episodes/24 hrs(12 Weeks)
研究者
研究点 (58)
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