A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 70
- 主要终点
- Number of participants who achieved a complete response
研究概览
简要总结
This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of PONV (postoperative nausea and vomiting) and/or motion sickness.
- •Have not smoked for the last 6 months.
- •Having certain abdominal, breast, thyroid or shoulder surgery.
排除标准
- •Pregnant or breastfeeding.
- •Have certain pre-existing medical conditions or take certain medications.
结局指标
主要结局
Number of participants who achieved a complete response
时间窗: Up to 24 hours
Complete response defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple. Vomiting defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit that is not productive of gastrointestinal contents (also known as "dry heaves"). Study participants who receive antiemetic rescue medication(s) during the initial 24 hours was considered treatment failures.
次要结局
- Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary(Up to 48 hours)
- Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary(Up to 48 hours)
- Number of participants with chemistry data outside the reference range(Up to 48 hours)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to Days 6-14 visit)
- Number of participants with first antiemetic rescue medication(Up to 48 hours)
- The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by an 11-point, linear, numerical rating scale referred to as a "0-10 Likert scale"(Up to 48 hours)
- The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by a categorical scale (none, mild, moderate or severe), as defined in the protocol(Up to 48 hours)
- Number of participants with first emetic event(Up to 48 hours)
- Number of participants with hematology data outside the reference range(Up to 48 hours)
- Safety and tolerability of the antiemetic regimens, assessed by clinical observation (including time to awakening from anesthesia, defined as ability to respond to a verbal command)(Up to 24 hours)