Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- Number of Participants Reporting One or More Adverse Drug Reactions
研究概览
简要总结
The purpose of this survey is to evaluate the safety (that is, frequency of adverse events) and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.
详细描述
This survey was designed to evaluate the safety (that is, frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 mg (Takepron Intravenous 30 mg) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.
For adults, 30 mg of lansoprazole is typically mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Participants with the following diseases for whom oral administration is not feasible:
- •Acute stress ulcer, and acute gastric mucosal lesions (both of which should be accompanied by bleeding).
排除标准
- 未提供
研究组 & 干预措施
30 mg of lansoprazole
30 mg of lansoprazole is mixed in physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Adverse Drug Reactions
时间窗: Baseline up to Week 9
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
次要结局
- Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment(Baseline up to Week 9)
- Percentage of Participants With Observed Hemostatic Effect(Baseline up to Week 9)
- Percentage of Participants With Confirmed Hemostatic Effect(Baseline up to Week 9)
- Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment(Week 17 (8 weeks after the last dose of study drug))