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

January 31, 2013 updated by: Baxter Healthcare Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

458

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai No. 6 Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Oliclinomel N4-550

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Prealbumin
Time Frame: Serum Prealbumin at Day 5
Serum Prealbumin at Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSPIVTCHN001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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