A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 990
- 试验地点
- 160
- 主要终点
- Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
研究概览
简要总结
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
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
- •Diagnosis of overactive bladder with symptoms for at least 6 months.
- •Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
- •Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception
排除标准
- •Conditions or prior treatment that may also affect bladder function
- •Clinically significant urinary tract infection (UTI)
- •Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
研究组 & 干预措施
Fesoterodine
干预措施: Fesoterodine 8 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
时间窗: Baseline, Week 12
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
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 episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
次要结局
- Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12(Baseline, Week 12)
- Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12(Baseline, Week 12)
- Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2(Week -2, Week 12)
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12(Baseline, Week 12)
- Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12(Baseline, Week 12)
- Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12(Baseline, Week 12)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12(Baseline, Week 12)
- Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline(Baseline, Week 12)
- Percentage of Participants With No UUI Episodes (Diary Dry Rate)(Week 4, Week 12)