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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579097
First Posted: April 17, 2012
Last Update Posted: February 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  Purpose
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.

Condition Intervention Phase
Nutrition Support Other: Oliclinomel N4 Other: Compounded ternary parenteral nutrition admixtures Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-Chamber Parenteral Nutrition Formulation (Oliclinomel N4)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Serum Prealbumin [ Time Frame: Serum Prealbumin at Day 5 ]

Enrollment: 458
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: compounded ternary parenteral nutrition
compounded ternary Parenteral Nutrition admixture
Other: Compounded ternary parenteral nutrition admixtures
Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days
Experimental: Oliclinomel N4 formulation
Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579097


Locations
China
Shanghai No. 6 Hospital
Shanghai, China
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01579097     History of Changes
Other Study ID Numbers: CSPIVTCHN001
First Submitted: April 13, 2012
First Posted: April 17, 2012
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Baxter Healthcare Corporation:
(PN) Parenteral nutrition
oral/enteral not possible