An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 20
- 主要终点
- Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes
研究概览
简要总结
This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant has symptoms of Overactive Bladder (OAB) (frequency and urgency) with Urge Urinary Incontinence (UUI) for a period of at least 6 months prior to screening.
- •Participant experiences ≥ 1 episode of UUI per day.
- •Participant has not been adequately managed with ≥ 1 oral or transdermal pharmacologic therapies for the treatment of their OAB symptoms.
排除标准
- •Participant has symptoms of OAB due to any known neurological reason (e.g., spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
- •Participant has a predominance of stress incontinence in the opinion of the investigator, determined by participant history.
- •Participant currently uses or plans to use medications or therapies to treat symptoms of OAB, including nocturia.
- •Participants who have previously been treated with onabotulinumtoxinA for urological indications within 12 months of starting the Screening Bladder Diary, or any other toxin for urological indications, regardless of when treated (participants treated with onabotulinumtoxinA or other toxins for non-urological indications are eligible, regardless of when treated)
研究组 & 干预措施
Cohort 1: URO-902 24 mg; Placebo
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
干预措施: URO-902 (Drug)
Cohort 1: URO-902 24 mg; Placebo
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
干预措施: Placebo (Drug)
Cohort 2: URO-902 48 mg; Placebo
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
干预措施: URO-902 (Drug)
Cohort 2: URO-902 48 mg; Placebo
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes
时间窗: Baseline (Day 1) and at Week 12
Average daily number of urgency episodes was calculated as the total number of urgency episodes recorded on a completed diary day within the visit window divided by the number of days the Bladder Diary was filled out. An urgency episode was defined as when a participant answered "Yes" to the question "Need to urinate immediately" on the bladder diary electronic case report form (eCRF). If a participant had more than 1 bladder diary filled out on the same day, then all the urgency episodes were summed together. The denominator used for calculating the average number only counted the days in which there was at least 1 completed bladder diary day within the visit window. Baseline was defined as the last non-missing measurement prior to the study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
次要结局
- Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Up to Week 48)