NCT01533766已完成3 期
A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega and SmofKabiven in Postoperative Patients Requiring Parenteral Nutrition
JW Life Science1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年8月最近更新:
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
- 50
- 试验地点
- 1
- 主要终点
- Comparison of adverse drug reaction
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of CombiflexOmega in comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 and older
- •Patients are expected to require PN for more than 5 days
- •Patients who voluntarily signed the consent form
排除标准
- •Patients are expected difficult to survive more than 5 days
- •Pregnant or breast-feeding women
- •BMI > 30 kg/m2
- •Patients with severe blood coagulation disorders
- •Patients with congenital amino acid metabolism disorders
- •Patients with acute shock
- •Patients with uncontrollable diabetes mellitus
- •Patients with hemophage syndrome
- •Patients with hypopotassemia (K < 3.0mEq/L)
- •Patients having the history of myocardial infarction
- •Patients reported the following laboratory value
- •fasting TG > 250mg/dl, TC > 300mg/dl
- •ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
- •Creatinine ≥ 1.5mg/dl
- •Ca > 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L
- •Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
- •Patients having the history of drug or alcohol abuse
- •General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation
- •Patients are in unstable conditions
- •Patients with difficult peripheral intravenous
- •Patients with parenteral nutrition within 7 days prior to start of the trial
- •Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study
- •Patients judged to be unsuitable for this trial by investigators
研究组 & 干预措施
CombiflexOmega
Experimental
干预措施: CombiflexOmega (Drug)
SmofKabiven
Active Comparator
干预措施: SmofKabiven (Drug)
结局指标
主要结局
Comparison of adverse drug reaction
时间窗: 6days
次要结局
- Changes of laboratory parameters (biochemistry, hematology, coagulation)(7days)
- Changes of vital signs(7days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral NutritionParentNCT01533298JW Life Science50
已完成
1 期
Radiotherapy & Combi in Metastatic MelanomaMetastatic MelanomaNCT02392871Melanoma and Skin Cancer Trials Limited10
终止
2 期
Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-IntronAdvanced CholangiocarcinomaNCT02982720Aiwu Ruth He, MD4
已完成
2 期
Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian CancerRecurrent Platinum Resistant Ovarian CancerNCT02889900AstraZeneca62
已完成
2 期
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal CancerBRAF V600E-mutant Metastatic Colorectal CancerNCT03693170Pierre Fabre Medicament95