NCT03323385已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety and Efficacy of Preoperative N1539 In Colorectal Surgery
Baudax Bio1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2017年10月24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
- 57
- 试验地点
- 1
- 主要终点
- Evaluation of Safety and Tolerability - Number of Subjects With an AE
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and incidence of Adverse Events (AEs) and Serious AEs (SAEs).
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
- •Voluntarily provide written informed consent.
- •Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis.
- •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.
- •Planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure.
- •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, with exception of events related to an ulcerative colitis diagnosis.
- •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
Evaluation of Safety and Tolerability - Number of Subjects With an AE
时间窗: Up to 30 days
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
次要结局
未报告次要终点
研究者
研究点 (1)
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