NCT00681356已完成3 期
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 24
- 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, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
详细描述
The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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, or III
- •Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)
排除标准
- •A body mass index (BMI) greater than 43
- •Known bleeding disorder or is taking agents affecting coagulation preoperatively
- •Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments
- •Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
- •Previous knee arthroplasty (partial or total) of the same knee
- •Participated in another clinical trial within 30 days prior to the planned TKA surgery
研究组 & 干预措施
3
Experimental
4975 - truncated for Phase 3
干预措施: 4975 - 5 mg (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo Comparator (Drug)
1
Experimental
4975 - 15 mg
干预措施: 4975, 15 and 5 mg (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 parameters, safety and tolerability of 4975(42 Days or Early Termination)
研究者
研究点 (24)
Loading locations...
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