A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Adynxx, Inc.
- 主要终点
- Pain with general movement involving the chest and upper body
研究概览
简要总结
This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale (PCS) scores undergoing mastectomy with immediate tissue expander or implant placement.
详细描述
Potential subjects will be prescreened for PCS score; pre-qualified patients will be invited to the investigative site for informed consent and full screening within 30 days of randomization. Patients providing informed consent and meeting all study eligibility criteria will be enrolled in the study on the day of surgery (Day 1).
Subjects will receive study drug just prior to anesthesia induction. Study assessments will be entered by subjects in the electronic diary from Day 1 through Day 21. Follow-up visits will occur on Days 7 and 21 (± 2 days).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Score of 16 or greater on the PCS scale
- •Scheduled to undergo unilateral or bilateral mastectomy with immediate tissue expander or implant placement
- •American Society of Anesthesiologists Physical Status Classification System ≤ 3
- •Medically stable for this surgery with general anesthesia and intrathecal administration of study drug as determined by the Investigator
- •Body mass index of 18-45 kg/m2
- •Have a stable medical regimen (for prescribed medications) for ≥ 7 days before randomization
- •Able to read and understand study instructions in English or Spanish, and willing and able to comply with all study procedures
排除标准
- •Prior breast surgery in the index breast (either breast for bilateral surgery) in the last two years, other than biopsies and small/moderate volume lumpectomies
- •Induction chemotherapy or plans for adjunctive chemotherapy or any radiotherapy within 21 days of surgery
- •Known spinal deformities or cutaneous infection in the lumbar area that would preclude intrathecal administration of study drug
- •Planned use of liposomal formulated or long-acting local anesthetics, extended release opioid formulations (e.g., Oxycontin), long half-life opioids (e.g., methadone), or drugs with potential for adverse cognitive or memory effects (e.g., ketamine, scopolamine, or propranolol) preoperatively and/or at any time through the duration of the study
- •Use of more than 40 mg per day (on average) of oral morphine or its equivalent within 1 month prior to randomization
- •Current neurologic disorder, which could confound the assessment of pain
- •Unstable mental condition which would prevent the patient from understanding the nature and scope of the study and/or evidence of an uncooperative attitude in the opinion of the Investigator
- •Women who are pregnant or nursing
- •Participation in a clinical trial with the last dose or intervention within 1 month of randomization, or planned treatment in a clinical trial during this study
- •Previous participation in any study involving brivoligide injection
研究组 & 干预措施
Brivoligide Injection 660 mg/6 mL
Subjects randomized to the brivoligide treatment group will receive a single 660 mg/6 mL intrathecal administration of brivoligide injection while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.
干预措施: Brivoligide Injection 660 mg/6 mL (Drug)
Placebo 6 mL
Subjects randomized to the placebo group will receive a single 6 mL intrathecal administration of placebo while in the lateral decubitus position at lumbar interspace L3/4 or higher. After injection subjects will be placed supine in a 15-degree head down tilt (Trendelenburg position) for 5 minutes and then returned to supine horizontal for surgery.
干预措施: Placebo 6 mL (Drug)
结局指标
主要结局
Pain with general movement involving the chest and upper body
时间窗: Day 3 to Day 14
Least Squares (LS) Mean pain rating with general movement involving the chest and upper body on the 0 - 10 Numerical Rating Scale (0 = No Pain; 10 = Worst Pain)
次要结局
- Pain at rest(Day 3 to Day 14)
- Pain with deep full inspiration and forceful effective cough(Day 3 to Day 14)
- Pain with ipsilateral arm abduction(Day 14 to Day 21)
- Total use of postoperative opioid medications(Day 1 through Day 21)
- Change from baseline for the BREAST-Q(Screening to Day 21)