NCT00611026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.
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
- 2,417
- 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
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 subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
- •Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
- •Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.
排除标准
- •Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
- •Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
- •OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
- •Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
研究组 & 干预措施
1
Active Comparator
干预措施: Tolterodine ER (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
3
Experimental
干预措施: Fesoterodine (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
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).
次要结局
- 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)
- Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Mean Number of Urgency Urinary Incontinence (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 Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)(Baseline, Week 1, Week 4, Week 12)
- Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary)(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 Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol)(Baseline, Week 1, Week 4, Week 12)
- Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary(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 Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol.(Baseline, Week 1, Week, 4, Week 12)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12(Baseline, Week 12)
- Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours.(Baseline, Week 1, Week 4, Week 12)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12(Baseline, Week 12)
研究者
研究点 (1)
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