NCT00683267终止2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 118
- 试验地点
- 9
- 主要终点
- Numerical Rating Scale (NRS) measures of pain at prespecified times
研究概览
简要总结
Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement
详细描述
The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, III
- •Planning to undergo unilateral THA
- •In good health and capable of undergoing THA with spinal block and sedation anesthesia
- •No additional planned surgeries during the course of the trial
- •Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English
排除标准
- •A body mass index greater than 40
- •Known bleeding disorder or is taking agents affecting coagulation preoperatively
- •A medical condition that could adversely impact the patient's participation, safety, or conduct of the study
- •Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
- •Previous hip arthroplasty of the same hip
- •Participated in another clinical trial within 30 days of the planned hip surgery
研究组 & 干预措施
1
Experimental
Study treatment, 4975, is instilled directly into surgical site
干预措施: 4975, highly purified capsaicin (Drug)
2
Placebo Comparator
Placebo is instilled directly into surgical site
干预措施: Placebo (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) measures of pain at prespecified times
时间窗: Primary endpoint is 2 days (4-48 hours)
次要结局
- Other efficacy endpoints, safety and tolerability of 4975(42 Days)
研究者
研究点 (9)
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