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

Phase 3

Completed

• Conditions: Nutrition Support
• Interventions: Other: Compounded ternary parenteral nutrition admixtures; Other: Oliclinomel N4

• Registration Number: NCT01579097
• Lead Sponsor: Baxter Healthcare Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Primary Completion: 2012-11
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compounded ternary parenteral nutrition	Compounded ternary parenteral nutrition admixtures	compounded ternary Parenteral Nutrition admixture
Oliclinomel N4 formulation	Oliclinomel N4	Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag

Primary Outcome Measures

Name	Time	Method
Serum Prealbumin	Serum Prealbumin at Day 5

Trial Locations

Locations (1)

Shanghai No. 6 Hospital; 🇨🇳 Shanghai, China