A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 888
- 试验地点
- 120
- 主要终点
- Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
研究概览
简要总结
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
干预措施: Placebo (Drug)
Mirabegron
Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug.
干预措施: Mirabegron (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours
时间窗: Baseline and EOT (up to 12 weeks)
A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.
Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours
时间窗: Baseline and EOT (up to 12 weeks)
An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.
次要结局
- Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Mean Volume Voided Per Micturition(Baseline and EOT (up to 12 weeks))
- Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Barthel Index of Daily Living Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and EOT (up to 12 weeks))
- Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours(End of treatment (up to 12 weeks))
- Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC(End of treatment (up to 12 weeks))
- Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in PPIUS(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)(Baseline and EOT (up to 12 weeks))
- Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit(Baseline and Weeks 4, 8 and EOT (up to 12 weeks))
- Percentage of Participants With Zero Incontinence Episodes Per 24 Hours(End of treatment (up to 12 weeks))
- Change From Baseline to EOT in OAB-q HRQL Subscale Scores(Baseline and EOT (up to 12 weeks))
- Percentage of Participants Who Achieved Micturition Frequency Normalization(End of treatment (up to 12 weeks))
- Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score(Baseline and EOT (up to 12 weeks))
- Change From Baseline in Post-void Residual Volume (PVR)(Baseline and EOT (up to 12 weeks))
- Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)(Baseline and EOT (up to 12 weeks))
- Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales(End of treatment (up to 12 weeks))
- Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC(End of treatment (up to 12 weeks))
- Number of Participants With Adverse Events (AEs)(From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks))