Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Texas
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Houston、Texas、美国、77402
- HD Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.
- Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2 and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of randomization.
- Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.
- Be willing and able to sign the informed consent form (ICF)
- Be willing and able to complete study procedures and pain scales and to communicate meaningfully in English. Be able and willing to return for outpatient follow up visits as required.
Key Exclusion Criteria:
In the opinion of the Investigator,
- have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period.
- have active skin disease or other clinically significant abnormality at the anticipated site of surgery that could interfere with the planned surgery.
- Have a known allergy to chili peppers, capsaicin or the components of CA-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.
- Have significant medical, neuropsychiatric or other condition.
The following are considered disallowed medications:
- tolerant to opioids as defined
- capsaicin-containing products or foods.
- central nervous system active agent as an analgesic adjunct medication
- antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection
- parenteral or oral corticosteroids.
- antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.
- Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:CA-008 5 mg (0.05 mg/mL) Cohort 1
Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008 (vocacapsaicin)
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5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
其他名称:
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安慰剂比较:Placebo - Cohort 1
Placebo for Cohort 1 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
安慰剂
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有源比较器:CA-008 10 mg (0.1 mg/mL) Cohort 2
Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008 (vocacapsaicin)
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5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
其他名称:
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有源比较器:CA-008 15 mg (0.15 mg/mL) Cohort 3
Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008 (vocacapsaicin)
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5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
其他名称:
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安慰剂比较:Placebo - Cohorts 2 and 3
Placebo - Cohorts 2 and 3 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
安慰剂
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo
大体时间:At 96 hours
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Primary Efficacy Endpoint for the Pilot Stage.
Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).
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At 96 hours
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CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours
大体时间:From 0 hours to 96 hours
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Primary Efficacy Endpoint for Stage 2. Area Under the Curve (AUC) of the NRS current pain intensity scores from Time 0 hours to 96 hours at rest (AUC0 to 96h) where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. • During the inpatient stay, NRS at rest beginning with the PACU admission may be assessed once the subject is awake. The maximum is an NRS score of 10 x all 96 hours = 960 NRS units*hrs; the minimum is 0 x 96h = 0 NRS units*hrs |
From 0 hours to 96 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of Subjects Who do Not Require Opioids
大体时间:Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
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Key Secondary Efficacy Endpoints for Stage 2. For each CA-008 dose vs. placebo comparison, percentage of subjects who do not require opioids.
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Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
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Total Opioid Consumption (in Daily Oral Morphine Equivalents)
大体时间:OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
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Key Secondary Efficacy Endpoints for Stage 2. Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
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OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
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合作者和调查者
调查人员
- 首席研究员:Daneshvari Solanki, MD、First Surgical Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
安慰剂的临床试验
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的