A Phase 2 Open-Label Study of HTX-011 Via Individualized Dosing Administration for Postoperative Analgesia Following Unilateral Simple Bunionectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores
研究概览
简要总结
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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. For cohort 2, acceptable contraceptives excludes hormonal contraceptives.
排除标准
- •Has had a contralateral foot bunionectomy in the past 3 months prior to the scheduled surgery.
- •Has a planned concurrent surgical procedure (eg, bilateral bunionectomy or collateral procedures on the surgical foot).
- •Has a 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 long-acting opioids within 3 days prior to the scheduled surgery.
- •Has taken any opioids within 24 hours prior to the scheduled surgery.
- •Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- •For Cohort 2 only, has been administered aprepitant or another NK1 receptor antagonist within 5 days prior to the scheduled surgery.
- •Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
- •Has initiated treatment with study 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.
- •For Cohort 2 only, is receiving pimozide, a strong or moderate CYP3A4 inhibitor, or a strong CYP3A4 inducer.
- •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 at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study.
- •Previously participated in an HTX-011 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 1: HTX-011
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.
干预措施: HTX-011 (Drug)
Treatment Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.
干预措施: Luer Lock applicator (Device)
Treatment Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.
干预措施: Vial access device (Device)
Treatment Group 2: HTX-011 + Aprepitant
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
干预措施: HTX-011 (Drug)
Treatment Group 2: HTX-011 + Aprepitant
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
干预措施: Luer Lock applicator (Device)
Treatment Group 2: HTX-011 + Aprepitant
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
干预措施: Vial access device (Device)
Treatment Group 2: HTX-011 + Aprepitant
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
干预措施: aprepitant (Drug)
Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.
干预措施: HTX-011 (Drug)
Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.
干预措施: Luer Lock applicator (Device)
Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen
HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.
干预措施: Vial access device (Device)
结局指标
主要结局
Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores
时间窗: 72 hours
Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).
次要结局
- Percentage of Subjects Receiving no Opioid Rescue(Day 7 and Day 28)
- Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores(72 hours)
- Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) Through 72 Hours(72 hours)
- Percentage of Subjects Receiving no Opioid Rescue(72 hours)