NCT04430088Unknown3 期
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 Bunionectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
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 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential.
- •Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal fixation (Austin 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.
排除标准
- •Subjects undergoing emergency or unplanned surgery.
- •Subjects who had any previous bunionectomy procedure on either foot.
- •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
Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
时间窗: 0-12 hours post-dose
Using Numeric Pain Rating Scale (NRS, 0-10)
次要结局
- Time to onset of perceptible pain relief using the double stopwatch method(0-12 hours post-dose)
- Total number of rescue medication request between 0-12 hours post-dose(0-12 hours post-dose)
- Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose(0-6 hours post-dose)
- Proportion of patients who take prescription opioid after discharge(2 weeks after discharge)
研究者
研究点 (3)
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