NCT03434275已完成3 期
A Phase 3b, Randomized, Double-Blind, Placebo-Control, Multicenter, Evaluation of the Safety and Efficacy of N1539 Administered Preoperatively in Open Unilateral Total Knee Arthroplasty
Baudax Bio1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2018年2月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Opioid Use Hour 0-24
研究概览
简要总结
The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent.
- •Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an inpatient setting for ≥24 hours, and receive at least two doses of study drug.
- •ASA physical status category 1, 2, or
- •Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
- •Have a body mass index <40 kg/m^2
排除标准
- •Have a known allergy or hypersensitivity to any study treatment.
- •Have a history of previous TKA.
- •Has plans for a concurrent surgical procedure (eg, bilateral TKA).
- •Has TKA planned to be performed under general anesthesia.
- •Have a history of myocardial infarction within the preceding 12 months.
- •Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
- •Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
- •Have a known bleeding disorder which may be worsened with the administration of an NSAID.
- •Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery.
- •Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication.
- •Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.
研究组 & 干预措施
N1539 30 mg
Experimental
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
干预措施: N1539 (Drug)
IV Placebo
Placebo Comparator
IV Placebo every 24 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Opioid Use Hour 0-24
时间窗: Up to 24 Hours
Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
次要结局
未报告次要终点
研究者
研究点 (1)
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