A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 4
- 主要终点
- Pain Intensity Scores
研究概览
简要总结
In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
- •Aged 18-80 years old
- •ASA physical class 1, 2, or 3
- •BMI </= 42 kg/m2
- •Generally healthy
排除标准
- •Concurrent condition requiring analgesic treatment during study period
- •Opioid tolerant
- •Known allergy to capsaicin or other study medication
- •Use of prohibited medications
研究组 & 干预措施
CA-008 60 mg
Single administration (0.5 mg/mL concentration)
干预措施: CA-008 (Drug)
CA-008 90 mg
Single administration (0.75 mg/mL concentration)
干预措施: CA-008 (Drug)
CA-008 36 mg
Single administration (0.3 mg/mL concentration)
干预措施: CA-008 (Drug)
Placebo
Single administration
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity Scores
时间窗: 0 to Day 15 post dose
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. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15
次要结局
- Total Opioid Consumption(0 to Day 15 post dose)