A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Stage Exploratory Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of Intraoperative Subacromial Injection With 4975 in Patients Undergoing Arthroscopic Rotator Cuff Repair of the Shoulder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study in patients undergoing arthroscopic rotator cuff repair surgery.
Stage 1) Patients will be randomized to receive either 4975 or placebo. The dose of 4975 will be escalated in a protocolized manner based on safety and tolerability.
Stage 2) Patients will be randomized in a 1:1 ratio to receive either the selected dose of 4975 or placebo. All patients will be observed in the hospital for at least two days following surgery for safety, tolerability, and efficacy assessments. In addition there will be two planned follow-up visits after hospital discharge.
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
- Double (Participant, Investigator)
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
- •Male or female between the ages of 18 and 75 inclusive
- •In overall good health and planning to undergo unilateral arthroscopic shoulder surgery to repair at least one rotator cuff tendon involving humeral attachment
- •Willing and able to complete the study procedures, pain assessments, and medication diaries, and to communicate in Korean or English with study personnel
排除标准
- •Shoulder surgery requiring concomitant repair of biceps muscle or associated tendon(s)
- •Planning to undergo shoulder surgery on both shoulders
- •Use of disallowed pain medications prior to the surgery
- •Female patients who are pregnant or lactating or who plan to get pregnant
- •Diabetes mellitus with a known HbA1C>9.5
研究组 & 干预措施
1
4975
干预措施: 4975 - Highly purified capsaicin (Drug)
2
4975
干预措施: 4975 - Highly purified capsaicin (Drug)
3
4975
干预措施: 4975 - Highly purified capsaicin (Drug)
4
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
时间窗: 28 Days
次要结局
- Mean overall daily pain and worst daily pain. Pain intensity with physical therapy. Safety outcomes include ECG, vital signs, adverse drug reactions, and wound exams(28 Days)