NCT04911062已完成2 期
A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery
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
- 32
- 试验地点
- 12
- 主要终点
- Incidence of Serious Adverse Events
研究概览
简要总结
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Optional Part B will be randomized, blinded, active-controlled.
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
- •Is scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia.
- •Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.
排除标准
- •Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- •Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
- •Has functioning intrathecal drug pump or spinal cord stimulator.
- •Opioid use for most days within the last 3 months.
- •Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled surgery.
- •Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
- •Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation.
- •Has impaired balance and is at risk of falling.
- •Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
- •Has undergone 3 or more surgeries within 12 months.
- •Has a known history of glucose-6-phosphate dehydrogenase deficiency.
- •Has History of liver cirrhosis, having an aspartate aminotransferase >3 × the upper limit of normal (ULN), or having an alanine aminotransferase >3 × ULN.
研究组 & 干预措施
Cohort 1: Bupivacaine HCl
Experimental
Bupivacaine HCl without epinephrine, via injection into the surgical site.
干预措施: Bupivacaine HCI without epinephrine (Drug)
Cohort 2: HTX-011
Experimental
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
干预措施: HTX-011 (Drug)
Cohort 2: HTX-011
Experimental
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
干预措施: Luer Lock Applicator (Device)
Cohort 3: HTX-011
Experimental
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
干预措施: HTX-011 (Drug)
Cohort 3: HTX-011
Experimental
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
干预措施: Luer Lock Applicator (Device)
结局指标
主要结局
Incidence of Serious Adverse Events
时间窗: From the time the subject signs the ICF through the Day 29 Visit
次要结局
- Time of occurrence of maximum concentration (Tmax)(Baseline through 120 hours)
- Maximum Observed Plasma Concentration (Cmax)(Baseline through 120 hours)
- Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)(Baseline through 120 hours)
- Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)(Baseline through 120 hours)
- Apparent terminal half-life (t½)(Baseline through 120 hours)
研究者
研究点 (12)
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