NCT00945763已完成2 期
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
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
- 230
- 试验地点
- 1
- 主要终点
- Pain Intensity Difference at End of Study
研究概览
简要总结
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
详细描述
This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of >2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction
排除标准
- •allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
- •use of aspirin or other analgesics within 48 hours prior to surgery
- •current or recent history of drug or alcohol abuse
- •any medication for treatment of chronic pain
- •clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
- •prior abdominal surgery, except uncomplicated appendectomy
- •any other surgical procedure within 30 days before administration of study drug
- •pregnancy or breastfeeding
- •untreated hypertension; SBP > 140 mmHg or DBP > 95 mmHg
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (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)
Motrin
Active Comparator
干预措施: Motrin (Drug)
结局指标
主要结局
Pain Intensity Difference at End of Study
时间窗: 0-24 hours
次要结局
- Onset of action(0-1 hour)
研究者
研究点 (1)
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