NCT03106623已完成2 期
Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 30
- 主要终点
- Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to combination of solifenacin succinate and mirabegron or placebo for 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with symptoms of overactive bladder for ≥6 months
排除标准
- •Patient with genuine stress incontinence, or with stress-predominant mixed urinary incontinence
- •Patient who has never experienced urge urinary incontinence during disease duration of overactive bladder
研究组 & 干预措施
ONO-8577 Arm
Experimental
Oral administration of ONO-8577 once a daily for 4 weeks
干预措施: ONO-8577 (Drug)
Active Comparator Arm
Active Comparator
Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
干预措施: solifenacin succinate + mirabegron (Drug)
Placebo Arm
Placebo Comparator
Oral administration of Placebo once a daily for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)
时间窗: Baseline and Week 4
次要结局
- Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)(Baseline and Week 2)
- Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)(Baseline and Week 4)
- Efficacy (Patient Global Impression at Week 4)(Week 4)
- Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition)(Baseline, Week 2 and 4)
- Pharmacokinetics (plasma concentration at one point on each visit)(Week 2 and 4)
- Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)(Baseline, Week 2 and 4)
- Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours)(Baseline, Week 2 and 4)
- Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours)(Baseline, Week 2 and 4)
- Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours)(Baseline, Week 2 and 4)
- Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4(Week 2 and 4)
- Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )(Baseline, Week 2 and 4)
- Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)(Up to Week 4)
- Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours)(Baseline, Week 2 and 4)
- Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)(Week 2 and 4)
研究者
研究点 (30)
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