NCT00546637已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.
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
- 947
- 试验地点
- 1
- 主要终点
- Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12
研究概览
简要总结
To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 40 years and above.
- •On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
- •Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.
排除标准
- •Contraindication to fesoterodine (antimuscarinics).
- •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 4mg or 8mg
Experimental
干预措施: Fesoterodine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12
时间窗: Baseline, Week 12
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 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
- Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4(Baseline, Week 4)
- Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and Week 12)
- Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4(Baseline, Week 4)
- Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12(Baseline, Week 12)
- Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4(Baseline, Week 4)
- Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12(Baseline, Week 12)
- Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4(Baseline, Week 4)
- Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.(Baseline, Week 12)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12(Baseline, Week 4 and 12)
- Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)(Baseline, Week 4 and 12)
- Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)(Baseline, Week 4 and Week 12)
- Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)(Baseline, Week 4 and Week 12)
- Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)(Baseline, Week 4 and Week 12)
- Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12(Baseline, Week 4, 8 and 12)
- Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12(Baseline, Week 12)
- Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)(Baseline, Week 12)
- Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)(Baseline, Week 12)
研究者
研究点 (1)
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