Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,000
- 试验地点
- 75
- 主要终点
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
详细描述
continuous registration method
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.
排除标准
- •Hypersensitivity to the active substance or to peanut or soya or any of the excipients
- •Urinary retention
- •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
- •Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)
研究组 & 干预措施
OAB-Toviaz
All patients who enrolled in this study
干预措施: Toviaz treatment (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.
Investigator's Final Assessment of Effectiveness at the End of Study Treatment
时间窗: At the end of study treatment
The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).
次要结局
- Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment(Baseline and at the end of study treatment)
- Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment(Baseline and at the end of study treatment)
- Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment(Baseline and at the end of study treatment)
- Participant Perception of Bladder Condition at the End of Study Treatment(Baseline and at the end of study treatment)
- Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics(At the end of study treatment)