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临床试验/NCT00786448
NCT00786448已完成不适用

Post-Marketing Surveillance Study Emselex

Bayer0 个研究点目标入组 5,821 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
5,821
主要终点
Adverse events, Adverse drug reactions, physician's global assessment of tolerability

研究概览

简要总结

  • Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.

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

入选标准

  • Patients who are treated with Emselex for Overactive Bladder

排除标准

  • Exclusion criteria are the contraindications as specified in the German product information

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

Adverse events, Adverse drug reactions, physician's global assessment of tolerability

时间窗: After 2-3 months of treatment (long-term 6 months)

次要结局

  • Incontinence(At end of study)
  • Urgency episodes(At end of study)
  • Micturitions / nycturitions(At end of study)
  • Physician's assessment of improvement/efficacy(At end of study)
  • Physician's assessment of patient's satisfaction with therapeutic effect(At end of study)
  • Physician's assessment of patient's ability to hold urine(At end of study)
  • Dose and treatment duration of Emselex(At end of study)

研究者

发起方
Bayer
申办方类型
Industry

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