NCT07821307已完成2 期
A Phase 2, Randomized, Double-Blind, Parallel Group, Exploratory Study to Evaluate the Efficacy and Safety of PCA Regimen of VVZ-149 Injections for the Treatment of Post-Operative Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Area under the pain intensity-time curve over 8 hours (AUC 8)
研究概览
简要总结
The purpose of this phase 2 study is to evaluate the efficacy and safety of PCA regimen of opiranserin (VVZ-149) injections in patients undergoing laparoscopic colectomy.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have the ability to voluntarily provide written informed consent, understand study
- •Men and women subjects aged ≥19 years and <75 years
- •Female subjects who are not pregnant or breastfeeding
- •Subjects must be undergoing a planned first laparoscopic colectomy
- •Subjects classified in American Society Anesthesiologist (ASA) risk class of I or II
排除标准
- •Subjects undergoing emergency or unplanned surgery
- •Subjects who had a previous laparoscopic colectomy or resection procedure
- •Subjects with pre-existing conditions causing preoperative pain around the site of surgery
- •Female subjects who are pregnant or breastfeeding
- •Diagnosis of chronic pain (e.g., persistent pain with the intensity of NRS ≥ 5 at baseline)
研究组 & 干预措施
VVZ-149 Injections + fentanyl PCA
Active Comparator
干预措施: VVZ-149 Injections (Drug)
VVZ-149 Injections PCA
Experimental
干预措施: VVZ-149 Injections (Drug)
VVZ-149 Injections + fentanyl PCA
Active Comparator
干预措施: Fentanyl (Drug)
结局指标
主要结局
Area under the pain intensity-time curve over 8 hours (AUC 8)
时间窗: 0-8 hours post-emergence
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). The area under the curve of the pain intensity over time graph from 0 to 8 hours will be calculated using pain intensity measured at scheduled time points and pre-rescue medication time points, as well as imputed values.
次要结局
- Number of PCA and rescue medication use and requests, and consumption measured at 2 hours for 12 hours post-emergence(0-12 hours post-emergence)
- Number of PCA and rescue medication use and requests, and consumption measured at 6 hours for 24 hours post-emergence(0-12 hours post-emergence)
研究者
jeayoun Kim
Clinical Assistant Professor
Samsung Medical Center
研究点 (1)
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