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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nutrition Support

Intervention / Treatment
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* Other: Oliclinomel N4
* Other: Compounded ternary parenteral nutrition admixtures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: compounded ternary parenteral nutrition<br>compounded ternary Parenteral Nutrition admixture | Other: Compounded ternary parenteral nutrition admixtures<br>* Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days<br>|
| Experimental: Oliclinomel N4 formulation<br>Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag | Other: Oliclinomel N4<br>* 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<br>* Other names: Oliclinomel N4-550;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Prealbumin |  | Serum Prealbumin at Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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(PN) Parenteral nutrition, oral/enteral not possible