A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Laparoscopic Colectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 5
- 主要终点
- Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)
研究概览
简要总结
The purpose of this phase 3 study is to evaluate the efficacy and safety of VVZ-149 Injections for the treatment of postoperative pain following 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are at least 18 years of age
- •Female subjects who are not pregnant or breastfeeding
- •Subjects undergoing a planned first laparoscopic colectomy
- •Subjects classified in American Society of Anesthesiologists (ASA) risk class of I or II
- •Subjects who report the pain intensity ≥ 5 on the NRS measured after surgery
- •Subjects who have the ability to understand study procedures and communicate clearly with the investigator and staff
- •Subjects who provide written informed consent prior to participation in the study
排除标准
- •Subjects undergoing emergency or unplanned surgery
- •Subjects who had a previous laparoscopic colectomy procedure, or who had any laparoscopic resection procedure
- •Subjects with pre-existing conditions causing preoperative pain at 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
干预措施: VVZ-149 Injections (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)
时间窗: 0-12 hours post-dose
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Time-weighted Sum of Pain Intensity Difference (PID) for 12 hours post-dose (SPID 12) was estimated using the linear trapezoidal rule (L x Hour) with the PI scores assigned from Time 0 to Time 12 hours post-dose using the following formula. The theoretical SPID 12 ranges from 0 to 120. A higher value of SPID indicates greater pain relief. SPID 12 = S \[T(i)-T(i-1)\] × \[PID(i)+PID(i-1)\]/2, when PID(i) =Predose PI-PI at Time i
次要结局
- Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose(0-12 hours post-dose)
- Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose(0-12 hours post-dose)