NCT00911937已完成4 期
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 963
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12
研究概览
简要总结
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
- •Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
- •Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)
排除标准
- •A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
- •Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
研究组 & 干预措施
Fesoterodine
Experimental
干预措施: Fesoterodine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12
时间窗: Baseline and Week 12
Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours
时间窗: Baseline
Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
次要结局
- Change From Baseline in Mean Voided Volume Per Micturition at Week 12(Baseline and Week 12)
- Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Mean Voided Volume Per Nocturnal Micturition(Baseline)
- Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)(Baseline)
- Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Number of Nocturnal Micturitions Per 24 Hours(Baseline)
- Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours(Baseline)
- Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score(Baseline)
- Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4(Baseline and Week 4)
- Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12(Baseline and Week 12)
- Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Mean Number of Micturitions Per 24 Hours(Baseline)
- Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Number of Micturition-related Urgency Episodes Per 24 Hours(Baseline)
- Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Nocturnal Frequency-urgency Sum Rating Per 24 Hours(Baseline)
- Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Frequency-urgency Sum Rating Per 24 Hours(Baseline)
- Mean Voided Volume Per Micturition(Baseline)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12(Baseline, Week 4 and 12)
研究者
研究点 (1)
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