A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study Conducted Under In-House Blinding Conditions, to Examine the Safety and Tolerability of IV MK0517 for the Prevention of Postoperative Nausea and Vomiting (PONV)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 主要终点
- Number of Patients With Clinical Adverse Experiences (CAEs)
研究概览
简要总结
A new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. This new medication is being compared to another intravenous medication that is already available to patients for this indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Open abdominal surgery requiring 24 hour hospital stay
- •General anesthesia
- •Post-operative opioids
- •ASA status of I-III
排除标准
- •Patient exhibits evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or cardiovascular condition or congestive heart failure (CHF)
- •Morbid obesity
- •Patient is mentally incapacitated or has a significant emotional or psychiatric disorder
结局指标
主要结局
Number of Patients With Clinical Adverse Experiences (CAEs)
时间窗: Baseline and 24 hours
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Number of Patients With Laboratory Adverse Experiences (LAEs)
时间窗: Baseline and 24 hours
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
次要结局
- Number of Patients With Drug-related CAEs(Baseline and 24 hours)
- Number of Patients With Serious CAEs(Baseline and 24 hours)