NCT00645281已完成4 期
Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 896 人开始时间: 2004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
- 已完成
- 发起方
- 入组人数
- 896
- 试验地点
- 1
- 主要终点
- Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-reported symptoms of OAB for ≥ 3 months prior to screening
- •OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
- •urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
- •patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale
排除标准
- •any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
- •any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
- •stress incontinence, functional, or overflow incontinence as determined by the investigator
- •symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
- •clinically significant urinary tract obstruction
- •history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
- •clinically significant interstitial cystitis or significant bladder pain syndrome
研究组 & 干预措施
tolterodine ER group
Experimental
干预措施: tolterodine extended release (Drug)
结局指标
主要结局
Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry
时间窗: 12 weeks
次要结局
- To asses the safety of tolterodine in patients with OAB(12 weeks)
- Change from baseline to Week 4 and 12 in micturition bladder diary variables(12 weeks)
- Change from baseline to Week 4 and 12 in AUA Symptom Index(12 weeks)
- Change from baseline to Week 4 and 12 in OAB questionnaire(12 weeks)
- Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12(12 weeks)
- OAB Bother Rating Scale at baseline(baseline)
- Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition(12 weeks)
- Clinical Global Impression-Improvement at Week 12(12 weeks)
研究者
研究点 (1)
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