A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 3
- 主要终点
- Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)
研究概览
简要总结
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).
详细描述
Primary Objective:
To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .
Secondary Objectives
- To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
- To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
- To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult aged 18 - 75 years old
- •American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
- •Planning elective Bunionectomy repair
- •For both males and females: using an acceptable method of birth control
- •If a female: not pregnant or breastfeeding
- •Have a body mass index ≤ 40 kg/m
- •Be willing and able to sign the informed consent form (ICF)
- •Be able to complete study procedures and pain scales and to communicate meaningfully in English
- •Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours
排除标准
- •Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
- •Have active skin disease or another 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, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
- •Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
- •Be on any medication not allowed per the protocol
- •Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
- •Have positive results on the alcohol test (breath or saliva) or urine drug screen
- •Have previously participated in a clinical study with CA-
- •Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)
研究组 & 干预措施
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)
Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: CA-008 (Drug)
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)
Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Ketorolac (Drug)
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)
Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Acetaminophen (Drug)
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)
Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Oxycodone (Drug)
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)
Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Bupivacaine Hydrochloride (Drug)
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)
Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: CA-008 (Drug)
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)
Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Ketorolac (Drug)
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)
Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Acetaminophen (Drug)
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)
Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Oxycodone (Drug)
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)
Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Bupivacaine Hydrochloride (Drug)
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)
Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: CA-008 (Drug)
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)
Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Ketorolac (Drug)
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)
Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Acetaminophen (Drug)
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)
Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Oxycodone (Drug)
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)
Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Bupivacaine Hydrochloride (Drug)
Placebo
Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Placebo (Drug)
Placebo
Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Ketorolac (Drug)
Placebo
Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Acetaminophen (Drug)
Placebo
Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Oxycodone (Drug)
Placebo
Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)
时间窗: [time frame: 96 hours]
Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose
次要结局
- Total Opioid Consumption (in Daily Morphine Equivalents)([time frame: 96 hours])
- Percentage of Subjects Opioid Free([time frame: 96 hours])