NCT03974932已完成3 期
A Phase 3b, Open-Label Study of HTX-011 as Part of a Scheduled Non-Opioid Multimodal Analgesic Regimen in Subjects Undergoing Total Knee Arthroplasty
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
- 116
- 试验地点
- 6
- 主要终点
- Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).
研究概览
简要总结
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
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
- Treatment
- 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
- 否
入选标准
- •Is scheduled to undergo primary unilateral TKA under spinal anesthesia.
- •Has not previously undergone TKA in either knee.
- •Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- •Is able to walk at least 20 feet with optional use of a 4-legged walker for balance.
- •Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or is at least 2 years post-menopausal; or is in a monogamous relationship with a partner who is surgically sterile; or using acceptable contraceptives.
排除标准
- •Has a planned concurrent surgical procedure.
- •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.
- •Using or expected to use Factor IX Complex or anti-inhibitor coagulant concentrates during the study.
- •Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- •Has taken NSAIDs within 10 days prior to the scheduled surgery with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
- •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 been administered any local anesthetic within 72 hours 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.
- •Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
- •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.
- •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.
- •Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
- •Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments.
- •Has acquired defective color vision or acute gastrointestinal ulcers, either of which could interfere with scheduled study medications.
- •Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature.
- •Has any chronic condition or disease that would compromise neurological or vascular assessments.
- •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.
- •Has a body mass index (BMI) >39 kg/m2.
研究组 & 干预措施
Cohort 4
Experimental
HTX-011 + MMA
干预措施: HTX-011 (Drug)
Cohort 4
Experimental
HTX-011 + MMA
干预措施: Ibuprofen (Drug)
Cohort 2
Experimental
HTX-011 + MMA
干预措施: HTX-011 (Drug)
Cohort 1
Experimental
HTX-011 + MMA
干预措施: HTX-011 (Drug)
Cohort 1
Experimental
HTX-011 + MMA
干预措施: Ibuprofen (Drug)
Cohort 2
Experimental
HTX-011 + MMA
干预措施: Ibuprofen (Drug)
Cohort 2
Experimental
HTX-011 + MMA
干预措施: Acetaminophen (Drug)
Cohort 1
Experimental
HTX-011 + MMA
干预措施: Acetaminophen (Drug)
Cohort 1
Experimental
HTX-011 + MMA
干预措施: Celecoxib (Drug)
Cohort 1
Experimental
HTX-011 + MMA
干预措施: Luer Lock Applicator (Device)
Cohort 2
Experimental
HTX-011 + MMA
干预措施: Celecoxib (Drug)
Cohort 2
Experimental
HTX-011 + MMA
干预措施: Luer Lock Applicator (Device)
Cohort 3
Experimental
HTX-011 + MMA
干预措施: Ibuprofen (Drug)
Cohort 3
Experimental
HTX-011 + MMA
干预措施: Acetaminophen (Drug)
Cohort 3
Experimental
HTX-011 + MMA
干预措施: Celecoxib (Drug)
Cohort 3
Experimental
HTX-011 + MMA
干预措施: +/- Bupivacaine HCl (Drug)
Cohort 3
Experimental
HTX-011 + MMA
干预措施: Luer Lock Applicator (Device)
Cohort 3
Experimental
HTX-011 + MMA
干预措施: HTX-011 (Drug)
Cohort 4
Experimental
HTX-011 + MMA
干预措施: Acetaminophen (Drug)
Cohort 4
Experimental
HTX-011 + MMA
干预措施: Luer Lock Applicator (Device)
结局指标
主要结局
Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).
时间窗: 12 through 48 hours
The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.
次要结局
- Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).(72 hours)
- Percentage of Subjects Who Are Opioid-free(72 Hours to Day 11)
- Median Time to First Opioid Rescue Medication.(Through 72 hours)
- Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).(72 hours)
- Percentage of Subjects Who Are Opioid-free Through 72 Hours Who Remain Opioid-free Through Day 11.(72 hours through Day 11)
- Median Time to First Ambulation Postsurgery.(72 hours)
- Maximum Concentration (Cmax)(72 hours)
- Percentage of Subjects With Severe Pain.(24 hours, 48 hours, 72 hours)
- Percentage of Subjects Who do Not Receive an Opioid Prescription Between Discharge and the Day 11 Visit.(72 hours through Day 11)
- Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).(24 hours, 48 hours, 72 hours, Day 11)
- Percentage of Subjects Who do Not Receive an Opioid Prescription at Discharge.(72 hours)
- Mean AUC of VAS Scores.(72 hours)
- Percentage of Subjects Who First Achieve an MPADSS Score ≥9.(2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24, hours, 36 hours, 48 hours, 60 hours, 72 hours)
- Percentage of Subjects Who Are Discharged Home vs to a Skilled Nursing Facility.(72 hours)
- Mean Overall Benefit of Analgesia Score (OBAS).(24 hours, 48 hours, 72 hours, Day 11)
- Mean Total TSQM-9 Score(72 hours through Day 11)
- Time of Occurrence of Maximum Concentration (Tmax)(72 hours)
- Percentage of Subjects Unable to Participate in Each Rehabilitation Session Because of Pain.(72 hours)
研究者
研究点 (6)
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