NCT00658684已完成3 期
An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine 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
- 153
- 试验地点
- 1
- 主要终点
- Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
研究概览
简要总结
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=1 per day.
排除标准
- •Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
- •Patient has a known neurological disease influencing bladder function.
- •Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
研究组 & 干预措施
Fesoterodine fumarate
Experimental
干预措施: fesoterodine fumarate (Drug)
结局指标
主要结局
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
时间窗: 52 Weeks
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
次要结局
- Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52(Week 4, 8, 28 and 52)
- Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52(Week 4, 8, 28 and 52)
- Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52(Week 4, 8, 28 and 52)
- Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52(Week 4, 8, 28 and 52)
- Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52(Week 4, 8, 28 and 52)
- Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52(Week 4, 8, 28 and 52)
- Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52(Week 28 and 52)
- Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52(Week 28 and 52)
- The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage(Week 28 and 52)
- Change From Baseline in Grade of PPBC at Week 28 and 52(Week 28 and 52)
研究者
研究点 (1)
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