NCT02540265已完成2 期
A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy
Baudax Bio1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Events
研究概览
简要总结
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent.
- •Male or female between 18 and 75 years of age, inclusive.
- •Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
- •Be American Society of Anesthesiology (ASA) physical class 1 or
- •Female subject are eligible only if all the following apply:
- •Not pregnant;
- •Not lactating;
- •Not planning to become pregnant during the study;
- •Commit to the use of an acceptable form of birth control for the duration of the study through Day
- •Have a body mass index ≤35 kg/m2
- •Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
排除标准
- •Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
- •Have a clinically significant abnormal clinical laboratory test value.
- •Have history of or positive test results for HIV, or hepatitis B or C.
- •Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
- •Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
- •Have another painful physical condition that may confound the assessments of post operative pain.
- •Have a history of syncope or other syncopal attacks.
- •Have evidence of a clinically significant 12 lead ECG abnormality.
- •Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse..
- •Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- •Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months.
- •Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with N
- •Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half lives of the specific prior medication (or, if half life is not known, within 48 hours) before dosing.
- •Have utilized corticosteroids, either systemically, inhalational either intranasally or oral, or by intra-articular injection, within 14 days prior to the study.
- •Have received any investigational product within 30 days before dosing with study medication.
- •Be receiving warfarin, lithium, or a combination of furosemide with either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker
- •Be currently receiving treatment with oral meloxicam (Mobic®)
- •Have previously received N1539 in clinical trials, or had bunionectomy in the last 3 months.
研究组 & 干预措施
N1539 30mg
Experimental
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
干预措施: N1539 (Drug)
N1539 60mg
Experimental
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
干预措施: N1539 (Drug)
IV Placebo
Placebo Comparator
IV Placebo every 24 hours for up to 3 doses.
干预措施: Intravenous Placebo (Drug)
结局指标
主要结局
Number of Subjects With Adverse Events
时间窗: Through Day 30 Follow-up
Number of subjects reporting treatment emergent adverse events
次要结局
- Number of Subjects With Use of Rescue Medication (Oral Opioids)(48 hours)
- Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)(48 Hours)
- Summed Pain Intensity Difference Over the First 48 Hours (SPID48)(48 Hours)
- Summed Pain Intensity Difference (SPID) at Other Intervals(48 Hours)
研究者
研究点 (1)
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