A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 794
- 试验地点
- 1
- 主要终点
- Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
研究概览
简要总结
The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.
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
- •Male or female ≥65 years old.
- •Overactive bladder symptoms for at least 3 months prior to study start.
- •Eight or more micturitions per 24 hours as confirmed by diary records
排除标准
- •Predominant Stress Urinary Incontinence
- •Active or recurrent bladder infections
- •Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.
研究组 & 干预措施
Placebo
Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated.
干预措施: Placebo (Drug)
Fesoterodine
Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after 4 weeks if clinically indicated. Subsequently the dose can be reduced to 4mg if clinically indicated.
干预措施: Fesoterodine fumarate (Drug)
结局指标
主要结局
Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
时间窗: Baseline and Week 12
Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (\>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.
次要结局
- Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Percentage of Participants Who Were Incontinent at Baseline and Became Dry(Weeks 8 to 12)
- Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12(Baseline and Weeks 4, 8, and 12)
- Percentage of Participants With Improvement at Week 12(Week 12)
- Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4(Baseline and Week 4)
- Change From Baseline in PPBC at Week 8(Baseline and Week 8)
- Change From Baseline in PPBC at Week 12(Baseline and Week 12)
- Change From Baseline in PPBC at Week 24(Baseline and Week 24)
- Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4(Baseline and Weeks 4)
- Change From Baseline in PPUS at Week 8(Baseline and Week 8)
- Change From Baseline in PPUS at Week 12(Baseline and Week 12)
- Change From Baseline in PPUS at Week 24(Baseline and Week 24)
- Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24(Baseline and Weeks 4, 8, 12, and 24)
- Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24(Baseline and Weeks 4, 8, 12, and 24)
- Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24(Baseline and Weeks 4, 8, 12, and 24)
- Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24(Weeks 12 and 24)
- Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24(Weeks 12 and 24)
- Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12(Baseline and Week 12)
- Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12(Baseline and Week 12)
- Change From Baseline in EQ-5D- Each Dimension Score at Week 12(Baseline and Week 12)
- Change From Baseline in Mini Mental State Examination (MMSE) at Week 12(Baseline and Week 12)