NCT06109415已完成4 期
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Total Shoulder Arthroplasty (TSA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs).
研究概览
简要总结
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).
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
- Double (Participant, 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
- •Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- •Is scheduled to undergo a unilateral Total Shoulder Arthroplasty.
排除标准
- •Is undergoing a revision surgery.
- •Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
- •History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
- •Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
- •Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
- •Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery.
- •Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors.
- •Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer).
- •Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years.
- •Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
- •Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- •Has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy).
- •Has a body mass index (BMI) >40 kg/m2.
研究组 & 干预措施
Treatment Group 2 Cohort 1
Active Comparator
Bupivacaine HCl + MMA regimen
干预措施: Acetaminophen (Drug)
Treatment Group 1 Cohort 1
Experimental
HTX-011 + multimodal analgesic (MMA) regimen
干预措施: HTX-011 (Drug)
Treatment Group 1 Cohort 1
Experimental
HTX-011 + multimodal analgesic (MMA) regimen
干预措施: Ibuprofen (Drug)
Treatment Group 1 Cohort 1
Experimental
HTX-011 + multimodal analgesic (MMA) regimen
干预措施: Acetaminophen (Drug)
Treatment Group 1 Cohort 1
Experimental
HTX-011 + multimodal analgesic (MMA) regimen
干预措施: Luer lock applicator (Device)
Treatment Group 2 Cohort 1
Active Comparator
Bupivacaine HCl + MMA regimen
干预措施: Bupivacaine Hydrochloride (Drug)
Treatment Group 2 Cohort 1
Active Comparator
Bupivacaine HCl + MMA regimen
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs).
时间窗: Through Day 15
次要结局
- Apparent terminal half-life (t½) of bupivacaine and meloxicam(Through 144 hours)
- Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam(Through 144 hours)
- Maximum concentration (Cmax) of bupivacaine and meloxicam(Through 144 hours)
- Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam(Through 144 hours)
- Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam(Through 144 hours)
研究者
研究点 (5)
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