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Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-chamber Parenteral Nutrition Formulation

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ClinicalTrials.gov Identifier: NCT01579097
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

April 13, 2012
April 17, 2012
February 1, 2013
December 2011
November 2012   (Final data collection date for primary outcome measure)
Serum Prealbumin [ Time Frame: Serum Prealbumin at Day 5 ]
Same as current
Complete list of historical versions of study NCT01579097 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-chamber Parenteral Nutrition Formulation
A Randomized, Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-Chamber Parenteral Nutrition Formulation (Oliclinomel N4)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Nutrition Support
  • Other: Oliclinomel N4
    Oliclinomel is a PN product which provides the macronutrients (e.g., dextrose, amino acids, and lipids) for patients when oral or enteral nutrition is not possible, insufficient, or contraindicated
    Other Name: Oliclinomel N4-550
  • Other: Compounded ternary parenteral nutrition admixtures
    Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days
  • Active Comparator: compounded ternary parenteral nutrition
    compounded ternary Parenteral Nutrition admixture
    Intervention: Other: Compounded ternary parenteral nutrition admixtures
  • Experimental: Oliclinomel N4 formulation
    Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag
    Intervention: Other: Oliclinomel N4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
458
400
January 2013
November 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01579097
CSPIVTCHN001
No
Not Provided
Not Provided
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Director: Baxter Investigative Site Shanghai, China
Study Director: Baxter Investigative Site Shantou, China
Study Director: Baxter Investigative Site Haikou, China
Study Director: Baxter Investigative Site Jiangsu Province, China
Study Director: Baxter Investigative Site Beijing, China
Study Director: Baxter Investigative Site Changsha, China
Study Director: Baxter Investigative Site Hangzhou, China
Study Director: Baxter Investigative Site Nanning, China
Study Director: Baxter Investigative Site Shang dong Province, China
Baxter Healthcare Corporation
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP