NCT01579097已完成3 期
A Randomized, Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-Chamber Parenteral Nutrition Formulation (Oliclinomel N4)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Serum Prealbumin
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient but hospitalized < 14 days prior to enrollment
- •Requires PN because oral or enteral nutrition is not possible, insufficient, or contraindicated
- •Has capability to complete at least 5 days of study treatment (i.e., PN)
- •Has a useable peripheral vein for delivery of intravenous (IV) PN
排除标准
- •Has a life expectancy of < 6 days from initiation of study treatment, in the opinion of the Investigator
- •Known hypersensitivity to the components of either of the investigational study treatments
- •Use of prohibited medications (e.g. glucocorticosteroids or antitumor chemotherapeutic agents) within 30 days prior to enrollment
- •Known serious clinically significant condition that would preclude participation in the study
- •Known chronic active hepatitis, elevated liver function tests
- •Known history of human immunodeficiency virus infection
- •Known severe dyslipidemia, severe hyperglycemia,clinically significant abnormalities of plasma electrolytes
- •Known pregnancy or lactation
结局指标
主要结局
Serum Prealbumin
时间窗: Serum Prealbumin at Day 5
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received TreatmentHIV InfectionsNCT00005017Glaxo Wellcome300
已完成
3 期
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria PatientsFalciparum MalariaNCT00403260Medicines for Malaria Venture1,271
撤回
3 期
Non-Inferiority Trial Comparing Eurofarma's Experimental Product Saccharomyces Boulardii Versus Floratil® in the Prevention of Antibiotic-Associated DiarrheaAntibioticsNCT01463943Eurofarma Laboratorios S.A.
已完成
3 期
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual MalesHigh-grade Anal Intraepithelial NeoplasiaNCT04055142Hospital Universitari Vall d'Hebron Research Institute108
进行中（未招募）
不适用
/AEUCTR2010-019577-16-IEGlaxoSmithKline Research & Development Ltd525