临床试验/NCT00921245

NCT00921245已完成不适用

First REal-life Evaluation of Darifenacin in Overactive Bladder Patients During 3 Months

Bayer0 个研究点目标入组 9 人开始时间: 2007年6月最近更新: 2015年4月20日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 9
主要终点: To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

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

•Male and female patients > 18 years with symptoms of overactive bladder.

排除标准

•Contraindications for the treatment with Darifenacin prolonged-release tablets according to the registered package insert.
•Pregnancy and lactation. Women of childbearing potential have to use an acceptable method of contraception.
•Concomitant treatment with drugs known to affect mainly the urinary bladder function (e.g. anticholinergics, antispasmodics) at any time during the study. Concomitant treatment with botulinum toxin, capsaicin or resiniferatoxin at any time during the study and treatment with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 1.

研究组 & 干预措施

Group 1

干预措施: Darifenacin (Emselex, BAY79-4998) (Drug)

结局指标

主要结局

To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome.

时间窗: 3 months later

次要结局

To evaluate the patient's perception of bladder condition, the patient's use of the patient support program, the patient's and physician's assessment of treatment regarding efficacy and tolerability and patient's compliance with the treatment(3 months later)

研究者

发起方

Bayer

申办方类型

Industry

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