NCT03997812已完成2 期
A 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 Bunionectomy
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
- 60
- 试验地点
- 2
- 主要终点
- Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion
研究概览
简要总结
The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.
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 must be between the ages of 18 to 70 years, inclusive. Female subjects must meet additional criteria in relation to childbearing potential.
- •Subjects must be undergoing a planned bunionectomy without collateral procedures.
- •Subjects must have the ability to provide written informed consent.
- •Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff.
- •Subjects must be classified as American Society of Anesthesiologists risk class I to II.
排除标准
- •Subjects undergoing emergency or unplanned surgery.
- •Subjects undergoing a repeat operation.
- •Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery.
- •Female subjects who are pregnant or breastfeeding.
- •Diagnosis of chronic pain 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 after the start of study drug infusion
时间窗: 0-12 hours after the start of study drug infusion
Using Numeric Pain Rating Scale (NRS, 0-10 at rest)
次要结局
- AUC of pain intensity for 24 hours after the start of study drug infusion.(0-24 hours after the start of study drug infusion)
- Total opioid consumption up to 24 hours after the start of study drug infusion.(0-24 hours after the start of study drug infusion)
- Time to perceptible, meaningful, and confirmed perceptible pain relief.(0-12 hours after the start of study drug infusion)
- Total opioid consumption up to 12 hours after the start of study drug infusion.(0-12 hours after the start of study drug infusion)
- Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.(0-24 hours after the start of study drug infusion)
- Time until the subject requested first and second rescue medications.(0-24 hours after the start of study drug infusion)
研究者
研究点 (2)
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