跳至主要内容
临床试验/NCT01088386
NCT01088386Enrolling By Invitation不适用

Zyprexa® Relprevv™ Patient Care Program

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2010年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
4,000
试验地点
1
主要终点
Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events

研究概览

简要总结

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).

详细描述

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:

  1. Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
  2. Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and
  3. Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.

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

  • Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient Care Program

排除标准

  • Any patient not receiving Zyprexa Relprevv

研究组 & 干预措施

Patients

All patients who will be receiving Zyprexa Relprevv must be enrolled into the Zyprexa Relprevv Patient Care Program

结局指标

主要结局

Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events

时间窗: Baseline to end of study

次要结局

  • Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome(Baseline to end of study)
  • Potential risk factors of post-injection delirium/sedation syndrome (PDSS).(Baseline to end of study)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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