跳至主要内容
临床试验/CTRI/2020/09/028152
CTRI/2020/09/028152已完成不适用

Retrospective, Prescription Event Monitoring (PEM) study of EMROK &/or EMROK – O (Levonadifloxacin)

Wockhardt Limited1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2020年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,500
试验地点
1
主要终点
Efficacy of EMROK &/or EMROK – O (Levonadifloxacin)

研究概览

简要总结

Wockhardt has designed this Retrospective, PrescriptionEvent Monitoring study of EMROK (LevonadifloxacinIntravenous Injection 800mg/100ml ) & EMROK – O (Levonadifloxacin Tablets 500mg) in real life setting. EMROK  andEMROK - O are indicated in adults with ≥18 years of age. Study end points covered will be: Incidencerates of adverse events, Improvement rate, Failure rate, Overall Global Assessment forEfficacy, Overall Global Assessment forSafety, Patient Demographiccharacteristics and Usage of EMROK Treatment.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Patients who were prescribed with EMROK or EMROK – O by their treating physicians.

排除标准

  • •Not applicable.

结局指标

主要结局

Efficacy of EMROK &/or EMROK – O (Levonadifloxacin)

时间窗: At the end of the study by Overall Global Assessment for Efficacy

次要结局

  • Safety of EMROK &/or EMROK – O (Levonadifloxacin)(At the end of the study by Overall Global Assessment for Safety)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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