Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 160
- 主要终点
- Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
研究概览
简要总结
This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, must be of nonreproductive potential
- •If male, must agree to use acceptable contraception
- •Symptoms of overactive bladder with urinary urgency incontinence
- •Inadequate response or limiting side effects with anticholinergics for the treatment of OAB
排除标准
- •Overactive bladder caused by neurological condition (eg, spinal cord injury, multiple sclerosis)
- •History of bladder surgery
- •Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks
- •Previous treatment with botulinum toxin therapy of any serotype for any urological condition
研究组 & 干预措施
AGN-214868 total dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
干预措施: AGN-214868 (Drug)
AGN-214868 total dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
干预措施: AGN-214868 (Drug)
AGN-214868 total dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
干预措施: AGN-214868 (Drug)
AGN-214868 total dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
干预措施: AGN-214868 (Drug)
AGN-214868 total dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
干预措施: AGN-214868 (Drug)
AGN-214868 total dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
干预措施: AGN-214868 (Drug)
Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
干预措施: AGN-214868 placebo (Drug)
结局指标
主要结局
Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
时间窗: Baseline, Week 12
The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).
次要结局
未报告次要终点