NCT03295721已完成3 期
A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 15
- 主要终点
- Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo.
研究概览
简要总结
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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
- •Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
- •Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- •Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
排除标准
- •Has had a contralateral foot bunionectomy in the past 3 months.
- •Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot).
- •Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
- •Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- •Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- •Has taken any NSAIDs within at least 10 days prior to the scheduled surgery.
- •Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
- •Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- •Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
- •Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
- •Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
- •As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
- •Has uncontrolled anxiety, psychiatric, or neurological disorder.
- •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 a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
- •Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
- •Has undergone 3 or more surgeries within 12 months.
- •Has a body mass index (BMI) >39 kg/m2.
研究组 & 干预措施
Treatment Group 2: Saline Placebo
Placebo Comparator
Saline placebo
干预措施: Luer-lock applicator (Device)
Treatment Group 1: HTX-011
Experimental
HTX 011 (bupivacaine/meloxicam)
干预措施: Luer-lock applicator (Device)
Treatment Group 1: HTX-011
Experimental
HTX 011 (bupivacaine/meloxicam)
干预措施: HTX-011 (Drug)
Treatment Group 1: HTX-011
Experimental
HTX 011 (bupivacaine/meloxicam)
干预措施: Vial access device (Device)
Treatment Group 2: Saline Placebo
Placebo Comparator
Saline placebo
干预措施: Saline Placebo (Drug)
Treatment Group 3: Bupivacaine HCI
Active Comparator
Bupivacaine HCl
干预措施: Bupivacaine HCl (Drug)
结局指标
主要结局
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo.
时间窗: 72 hours
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight bearing).
次要结局
- Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl.(72 hours)
- Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.(72 hours)
- Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.(72 hours)
- Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.(72 hours)
研究者
研究点 (15)
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