A Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 616
- 试验地点
- 1
- 主要终点
- Cumulative Pain Score
研究概览
简要总结
Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.
详细描述
After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. Subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. Follow-up will then occur at 7 and 30 days afterwards.
The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms.
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
- •Ability to sign ICF
- •Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
- •BMI ≤ 39 kg/m2
- •If biologically female, not pregnant or planning to become pregnant over the study
- •If biologically male, either sterile or using acceptable form of birth control
- •Be willing and able to complete study procedures
排除标准
- •Has previously undergone unilateral simple bunionectomy.
- •Has a planned concurrent surgical procedure
- •Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments
- •Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments.
- •Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
- •Has history or evidence of impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
- •Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN).
- •Has a history of malignancy in the past year
- •Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months
研究组 & 干预措施
Ropivacaine HCl
Local infiltration of study drug
干预措施: Naropin, 0.5% Injectable Solution (Drug)
CPL-01
Local infiltration of study drug
干预措施: Local anesthetic injection of CPL-01 (Drug)
Placebo
Local infiltration of study drug
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative Pain Score
时间窗: 72 hours
Area Under the Curve of the Numeric Rating Scale Score for Pain with Activity. Activity is resting the operative foot with the ball on the floor. Pain Score spans from 0 to 10, where 0 is no pain and 10 is worst pain imaginable.
次要结局
未报告次要终点