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Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

2018年10月4日 更新者：Pfizer

Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.

This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.

研究概览

地位

完全的

条件

干预/治疗

详细说明

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

研究类型

观察性的

注册 (实际的)

823

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 斯洛伐克
      • ?a?a、斯洛伐克
        • Pfizer Investigational Site
      • Aa、斯洛伐克
        • Pfizer Investigational Site
      • Adca、斯洛伐克
        • Pfizer Investigational Site
      • B.Bystrica、斯洛伐克
        • Pfizer Investigational Site
      • Banska Bystrica、斯洛伐克、974 01
        • Pfizer Investigational Site
      • Bardejov、斯洛伐克
        • Pfizer Investigational Site
      • Bratislava、斯洛伐克
        • Pfizer Investigational Site
      • Bratislava、斯洛伐克、82606
        • Pfizer Investigational Site
      • Bratislava、斯洛伐克、833 05
        • Pfizer Investigational Site
      • Bratislava、斯洛伐克、851 01
        • Pfizer Investigational Site
      • Bratislava、斯洛伐克、851 05
        • Pfizer Investigational Site
      • Bratislava 2、斯洛伐克、82109
        • Pfizer Investigational Site
      • Bratislava 2、斯洛伐克、82606
        • Pfizer Investigational Site
      • Bratislava 4、斯洛伐克
        • Pfizer Investigational Site
      • Bratislava 5、斯洛伐克、85104
        • Pfizer Investigational Site
      • Bratislava 5、斯洛伐克、85107
        • Pfizer Investigational Site
      • Dolny Kubin、斯洛伐克
        • Pfizer Investigational Site
      • Dunajska Streda、斯洛伐克
        • Pfizer Investigational Site
      • Hlohovec、斯洛伐克
        • Pfizer Investigational Site
      • Humenne、斯洛伐克
        • Pfizer Investigational Site
      • Ilina、斯洛伐克
        • Pfizer Investigational Site
      • Koice、斯洛伐克
        • Pfizer Investigational Site
      • Koice-aca、斯洛伐克
        • Pfizer Investigational Site
      • Komarno、斯洛伐克
        • Pfizer Investigational Site
      • Kosice、斯洛伐克、041 90
        • Pfizer Investigational Site
      • Kosice、斯洛伐克
        • Pfizer Investigational Site
      • Kraovsky Chlmec、斯洛伐克
        • Pfizer Investigational Site
      • Liptovsky Hradok、斯洛伐克
        • Pfizer Investigational Site
      • Liptovsky Mikulas、斯洛伐克
        • Pfizer Investigational Site
      • Luenec、斯洛伐克
        • Pfizer Investigational Site
      • Malacky、斯洛伐克、901 01
        • Pfizer Investigational Site
      • Malacky、斯洛伐克、90122
        • Pfizer Investigational Site
      • Martin、斯洛伐克
        • Pfizer Investigational Site
      • Michalovce、斯洛伐克
        • Pfizer Investigational Site
      • Myjava、斯洛伐克
        • Pfizer Investigational Site
      • Namestovo、斯洛伐克
        • Pfizer Investigational Site
      • Nitra、斯洛伐克、949 01
        • Pfizer Investigational Site
      • Nitra、斯洛伐克、951 01
        • Pfizer Investigational Site
      • Nitra、斯洛伐克
        • Pfizer Investigational Site
      • Nove Zamky、斯洛伐克
        • Pfizer Investigational Site
      • Nové Zámky、斯洛伐克
        • Pfizer Investigational Site
      • Piestany、斯洛伐克、921 01
        • Pfizer Investigational Site
      • Poprad、斯洛伐克
        • Pfizer Investigational Site
      • Povaska Bystrica、斯洛伐克
        • Pfizer Investigational Site
      • Povazska Bystrica、斯洛伐克、017 01
        • Pfizer Investigational Site
      • Preov、斯洛伐克
        • Pfizer Investigational Site
      • Prievidza、斯洛伐克
        • Pfizer Investigational Site
      • Puchov、斯洛伐克
        • Pfizer Investigational Site
      • Revuca、斯洛伐克
        • Pfizer Investigational Site
      • Rimavska Sobota、斯洛伐克
        • Pfizer Investigational Site
      • Ruomberok、斯洛伐克
        • Pfizer Investigational Site
      • Ruzomberok、斯洛伐克
        • Pfizer Investigational Site
      • Senica、斯洛伐克、90501
        • Pfizer Investigational Site
      • Skalica、斯洛伐克、90901
        • Pfizer Investigational Site
      • Sobrance、斯洛伐克
        • Pfizer Investigational Site
      • SpisskaNova Ves、斯洛伐克
        • Pfizer Investigational Site
      • Stropkov、斯洛伐克
        • Pfizer Investigational Site
      • Svidnik、斯洛伐克
        • Pfizer Investigational Site
      • Topoany、斯洛伐克
        • Pfizer Investigational Site
      • Trebisov、斯洛伐克
        • Pfizer Investigational Site
      • Trencin、斯洛伐克、911 01
        • Pfizer Investigational Site
      • Trenin、斯洛伐克
        • Pfizer Investigational Site
      • Trnava、斯洛伐克
        • Pfizer Investigational Site
      • Turianske Teplice、斯洛伐克
        • Pfizer Investigational Site
      • Urany、斯洛伐克
        • Pfizer Investigational Site
      • Vrable、斯洛伐克
        • Pfizer Investigational Site
      • Vranov n/Topou、斯洛伐克
        • Pfizer Investigational Site
      • Zvolen、斯洛伐克
        • Pfizer Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

描述

Inclusion Criteria:

  • Patients older than 18 years
  • Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
  • Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
  • Due to intolerance: persistent and/or unacceptable adverse events

Exclusion Criteria:

  • Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
  • History of acute urinary retention (requiring catheterisation)
  • Gastric retention
  • Uncontrolled narrow angle glaucoma
  • Myasthenia gravis
  • Severe hepatic impairment (Child Pugh C)
  • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
  • Severe ulcerative colitis
  • Toxic megacolon.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：仅案例
  • 时间观点：预期

队列和干预

团体/队列
干预/治疗
fesoterodine
药品：fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
其他名称：
  • TOVIAZ

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
大体时间：Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
大体时间：Baseline, Month 1, Month 2, Month 3 or ET
Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
大体时间：Baseline, Month 1, Month 2, Month 3 or ET
UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).
Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
大体时间：Baseline, Month 1, Month 2, Month 3 or ET
The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or ET

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
大体时间：Baseline, Month 1, Month 2, Month 3 or ET
The PVR urine volume: measured by an ultrasound scan.
Baseline, Month 1, Month 2, Month 3 or ET
Patient's Global Evaluation of Fesoterodine
大体时间：Baseline, Month 3 or ET
The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.
Baseline, Month 3 or ET
Clinical Global Evaluation of Fesoterodine
大体时间：12 weeks
Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'
12 weeks
Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
大体时间：Month 3 or ET
Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.
Month 3 or ET
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
大体时间：Baseline, Month 3 or ET
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Baseline, Month 3 or ET
Change From Baseline in Total Scores of OAB-q at Visit 4
大体时间：Baseline, Month 3 or ET
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Baseline, Month 3 or ET
Time To Onset Of Treatment Response
大体时间：Month 1, Month 2, Month 3 or ET
Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
Month 1, Month 2, Month 3 or ET
Study Doses
大体时间：Month 3 or ET
Number of subjects that changed doses throughout the study period.
Month 3 or ET
Reasons for Study Treatment Dose Changes
大体时间：Month 3 or ET
Possible change in the dose and the reasons for the change were collected and documented.
Month 3 or ET

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年7月1日

初级完成 (实际的)

2009年6月1日

研究完成 (实际的)

2009年6月1日

研究注册日期

首次提交

2008年6月3日

首先提交符合 QC 标准的

2008年6月4日

首次发布 (估计)

2008年6月5日

研究记录更新

最后更新发布 (实际的)

2018年11月2日

上次提交的符合 QC 标准的更新

2018年10月4日

最后验证

2018年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A0221059

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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