NCT05260008终止2 期
A Phase 2B, Randomized, Double Blind, Active Comparator, Multicenter, Safety, and Efficacy Trial of ATX-101 in Subjects Undergoing Total Knee Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 13
- 主要终点
- Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity.
研究概览
简要总结
This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis.
- •Scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted).
- •American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2 or 3.
排除标准
- •Has a planned concurrent surgical procedure.
- •Has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening.
- •Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee.
- •Immunocompromised or has a known history of Hepatitis B, human immunodeficiency virus (HIV), or Hepatitis C.
- •Routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial.
- •Unable to abstain from opioid use for knee pain within 14 days of surgery.
- •Has been administered systemic steroids within 14 days prior to surgery.
- •Has been administered any local anesthetic within 5 days prior to the scheduled surgery.
- •Screening electrocardiogram (ECG) with significant abnormalities associated with significant heart disease.
- •Has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications.
- •Has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments.
- •Has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome.
- •Has a known or suspected history of drug or alcohol abuse. A subject with a history of alcohol use disorder that has ≥10 years sobriety will be permitted.
- •Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine.
- •Has a Body Mass Index (BMI) ≥45 kg/m2
研究组 & 干预措施
ATX-101 Dose A
Experimental
ATX-101 Dose A
干预措施: ATX-101 (Drug)
ATX-101 Dose B
Experimental
ATX-101 Dose B
干预措施: ATX-101 (Drug)
bupivacaine hydrochloride
Active Comparator
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
干预措施: bupivacaine hydrochloride without epinephrine (Drug)
结局指标
主要结局
Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity.
时间窗: from 30 minutes post-surgery through hour 168 (Day 8)
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
次要结局
- Percentage of Subject Who Remain Opioid Free.(Surgical Closure to Day 30)
- Time to First Rescue Opioid Medication.(Surgical Closure to Day 30)
- Total Post-surgical Use of Rescue Opioid Medications.(Surgical Closure to Day 30, Opioid consumption is summarized descriptively every 24-hour period through Day 30)
研究者
研究点 (13)
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