NCT01302938终止4 期
Exploratory, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center, Web-Based Phase IV Pilot Methodology Trial To Evaluate The Efficacy And Safety Of Tolterodine ER In Subjects With Overactive Bladder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
研究概览
简要总结
To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female and 21 years or older
- •Overactive bladder symptoms (subject-reported) for at least 3 months
- •Be resident in the United States of America and have access and be able to use a computer with internet access throughout the duration of the study
排除标准
- •Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.
- •History of cystitis, continence, urogenitalcancer or radiation
- •Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.
研究组 & 干预措施
Tolterodine ER
Experimental
干预措施: Tolterodine ER (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
时间窗: Baseline, Week 12
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
次要结局
- Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4(Baseline, Week 1, 4)
- Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12(Baseline, Week 1, 4, 12)
- Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12(Baseline, Week 1, 4, 12)
- Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12(Baseline, Week 1, 4, 12)
- Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12(Baseline, Week 1, 4, 12)
- Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12(Baseline, Week 1, 4, 12)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12(Baseline, Week 12)
- Number of Participants With Reason for Participation in the Study(Week 12)
- Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12(Baseline, Week 1, 4, 12)
- Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12(Baseline (Bl), Week 1, 4, 12)
- Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12(Baseline, Week 12)
- Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12(Baseline, Week 12)
- Participant Perception Regarding Received Treatment in the Study(Week 12)
- Number of Participants With Response Regarding Source of First Information About Study(Week 12)
- Participant Perception Regarding Satisfaction Related to Study(Week 12)
- Participant Perception Regarding Cell Phone Diary(Week 12)
- Participant Perception Regarding Recommending a Friend to Enter Similar Study(Week 12)
研究者
研究点 (2)
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