NCT00536484已完成3 期
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 896
- 试验地点
- 1
- 主要终点
- Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
研究概览
简要总结
This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overactive bladder symptoms for greater than or equal to 3 months.
- •Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
- •Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.
排除标准
- •Contraindication to fesoterodine (antimuscarinics).
- •Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
- •Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
- •Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
研究组 & 干预措施
Fesoterodine (Double-Blind)
Experimental
干预措施: Fesoterodine (Drug)
Placebo (Double-Blind)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
时间窗: Baseline and Week 12
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline
次要结局
- Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline(Baseline, Week 2 and Week 6)
- Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale(Baseline and Week 12)
- Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales(Baseline and Week 12)
- Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
- Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline(Baseline, Week 2, Week 6 and Week 12)
研究者
研究点 (1)
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