NCT03997838已完成3 期
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled Trial to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 5
- 主要终点
- Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence
研究概览
简要总结
The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following abdominoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 18-70 years old, inclusive. Female subjects must meet additional criteria according to childbearing potential.
- •Planning to undergo abdominoplasty
- •Ability to provide written informed consent
- •Ability to understand study procedures and communicate clearly with the investigator and staff
- •American Society of Anesthesiologists (ASA) risk class of I to II.
排除标准
- •Emergency or unplanned surgery
- •Previous abdominoplasty
- •Pre-existing condition causing preoperative pain around the site of surgery
- •Women who are pregnant or breastfeeding
- •Chronic pain diagnosis and ongoing or frequent use of pain medications
研究组 & 干预措施
VVZ-149 Injections
Experimental
干预措施: VVZ-149 Injections (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence
时间窗: 0-12 hours post-emergence
Using Numeric Pain Rating Scale (NRS, 0-10 at rest)
次要结局
- Total number of requests for rescue medication for 24 hours post-emergence(0-24 hours post-emergence)
- Total amount of rescue medication consumption for 12 hours post-emergence(0-12 hours post-emergence)
- Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence(0-24 hours post-emergence)
- Total amount of intra-operative fentanyl use(During surgery)
研究者
研究点 (5)
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