NCT00444925已完成3 期
12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)
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
- 1,712
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
研究概览
简要总结
To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and 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
- Triple (Participant, Care Provider, Investigator)
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
- •Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day
排除标准
- •Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
- •Patients with significant hepatic and renal disease or other significant unstable diseases.
- •OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
研究组 & 干预措施
Placebo
Placebo Comparator
Tablets and capsules
干预措施: placebo (Drug)
Fesoterodine
Experimental
Tablets
干预措施: fesoterodine fumarate (Drug)
Tolterodine
Active Comparator
Capsules
干预措施: tolterodine tartrate (Drug)
结局指标
主要结局
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
时间窗: Baseline, Week 12
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.
次要结局
- Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.(Baseline, Week 1, Week 4)
- Percent Change From Baseline of UUI Episodes Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Mean Voided Volume Per Micturition.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Mean Number of Micturitions Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Percent Change From Baseline of Micturitions Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Percent Change From Baseline of Urgency Episodes Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Patient Perception of Bladder Condition (PPBC).(Baseline, Week 1, Week, 4, Week 12)
- Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).(Baseline, Week 12)
- Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).(Baseline, Week 12)
研究者
研究点 (1)
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