NCT05337228已完成3 期
A Randomized, Open-label, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301 in Postoperative Patients Requiring Peripheral Parenteral Nutrition
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Adverse drug reaction rate
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.
详细描述
This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 Peri inj. or RPN301)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 19 at the time of obtaining the informed consent form
- •Requiring over 3 days of parenteral nutrition via a peripheral vein after an operation
- •BMI 16 ~ 30 kg/㎡
排除标准
- •Has received parenteral nutrition within 7 days of screening
- •Severe dyslipidemia
- •Uncontrolled diabetes
- •Clinically significant liver disease
- •Clinically significant kidney disease
研究组 & 干预措施
IN-C006 Peri inj.
Experimental
IN-C006 Peri inj. 1904 mL
干预措施: IN-C006 Peri inj. (Drug)
RPN301
Active Comparator
RPN301 2020 mL
干预措施: RPN301 (Drug)
结局指标
主要结局
Adverse drug reaction rate
时间窗: Day 1 to Day 4
Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation
次要结局
- Change in inflammation parameters(hs-CRP)(Day 1 to Day 4)
- Change in vital sign (Body temperature)(Day 1 to Day 4)
- Change in inflammation parameters(TNF-α)(Day 1 to Day 4)
- Change in nutritional management parameters(Nitrogen balance)(Day 1 to Day 4)
- Change in nutritional management parameters(Prealbumin)(Day 1 to Day 4)
- Change in nutritional management parameters(Albumin)(Day 1 to Day 4)
- Change in inflammation parameters(IL-6)(Day 1 to Day 4)
- Change in nutritional management parameters(Transferrin)(Day 1 to Day 4)
- Change in fatty acid profile(Day 1 to Day 4)
- Incidence of Adverse event(Day 1 to Day 4)
- Change in laboratory parameters (Hematology)(Day 1 to Day 4)
- Change in laboratory parameters (Blood chemistry)(Day 1 to Day 4)
- Change in laboratory parameters (Blood coagulation test)(Day 1 to Day 4)
- Change in laboratory parameters (Urinalysis)(Day 1 to Day 4)
- Change in vital sign (Respiratory rate)(Day 1 to Day 4)
- Change in vital sign (Blood pressure)(Day 1 to Day 4)
- Change in vital sign (Pulse rate)(Day 1 to Day 4)
- Normal and abnormal change in physical examination (Frequency)(Day 1 to Day 4)
- Normal and abnormal change in physical examination (Ratio)(Day 1 to Day 4)
研究者
研究点 (1)
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