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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01579097
First received: April 13, 2012
Last updated: January 31, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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
Other Name: Compounded ternary parenteral nutrition admixtures
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01579097     History of Changes
Other Study ID Numbers: CSPIVTCHN001
Study First Received: April 13, 2012
Last Updated: January 31, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014