NCT01436032终止3 期
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24)
研究概览
简要总结
The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified
排除标准
- •Use of ketorolac is contraindicated
- •Use of general anesthesia is contraindicated
- •Has a medical condition that could adversely impact subject participation
- •Has diabetes mellitus and glycosylated hemoglobin (HbA1c) >9.5 or history of prolonged uncontrolled diabetes
- •Body mass index (BMI) less than 18 or greater than 35
- •Has a history of intolerance or allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, aspirin or other salicylates
- •Known or suspected sleep apnea
- •History of Hepatitis B or C
- •Has a psychiatric disorder that impairs capability of subject to report pain
- •Known to have chronic obstructive pulmonary disease (COPD) with carbon dioxide retention or chronic hypoxemia
研究组 & 干预措施
N1539 15 mg
Experimental
干预措施: N1539 (Drug)
N1539 30 mg
Experimental
干预措施: N1539 (Drug)
Ketorolac
Active Comparator
IV
干预措施: Ketorolac Tromethamine (Drug)
Placebo
Placebo Comparator
IV
干预措施: Placebo (Drug)
N1539 7.5mg
Experimental
干预措施: N1539 (Drug)
结局指标
主要结局
Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24)
时间窗: 0 to 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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