NCT01084161已完成2 期
A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 486
- 主要终点
- To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.
研究概览
简要总结
To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •moderate to severe pain with VAS of >/= 45 mm
- •undergo open abdominal hysterectomy
- •ASA I or II
- •signed ICF
- •BMI >18.5 and < 31.5 kg/m^2
排除标准
- •suspected metastatic cervical or endometrial cancer
- •prior abdominal surgery with postoperative complications
- •active pancreatitis, obstruction of biliary tree or total bilirubin> 2.5 mg/dL
- •active GI bleeding, or peptic ulcer disease
- •unstable medical condition
- •HbA1c >9.5 or uncontrolled diabetes
- •SBP >150 mmHg or DBP > 95 mmHg
- •personal or familial contraindication to undergoing general anesthesia
- •Antihypertensive agents or diabetic regimen that is not stable (4 weeks prior to surgery)
- •taking CNS agents for pain
- •acetaminophen or NSAIDs not discontinued for at least 5 half-lives prior to planned surgery
- •currently taking an opioid or has taken an opioid chronically for pain in past 2 years
- •corticosteroid or systemic corticosteroids within 6 weeks of planned surgery
- •has a known bleeding disorder or taking agents affecting coagulation
- •history of intolerance or allergic reactions to NSAIDs, COX-2 inhibitors, aspirin and other salicylates
- •receiving lithium or a combination of furosemide with an ACE inhibitor or angiotensin receptor blocker
- •Known to have sleep apnea
- •History of hepatitis B or C
- •AST or ALT > 2 times the upper limit of normal
- •Known or suspected COPD with retention of carbon dioxide
- •psychiatric condition that impairs the capability of the subject to report pain
研究组 & 干预措施
N1539 5 mg
Experimental
干预措施: N1539 (Drug)
N1539 7.5 mg
Experimental
干预措施: N1539 (Drug)
N1539 15 mg
Experimental
干预措施: N1539 (Drug)
N1539 30 mg
Experimental
干预措施: N1539 (Drug)
N1539 60 mg
Experimental
干预措施: N1539 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
morphine
Active Comparator
干预措施: Morphine (Drug)
结局指标
主要结局
To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.
时间窗: at 60 minutes post dose and at 24 hours
Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.
次要结局
- To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events(5-7 days post initial dosing)
研究者
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