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

Nutrition Support Clinical Trial

Official title:

A Randomized, Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-Chamber Parenteral Nutrition Formulation (Oliclinomel N4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579097
• Other study ID #: CSPIVTCHN001
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2012
• Last updated: January 31, 2013
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nutrition Support

Intervention

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
• Compounded ternary parenteral nutrition admixtures
Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days

Locations

Country	Name	City	State
China	Shanghai No. 6 Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Prealbumin		Serum Prealbumin at Day 5	No