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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01579097

Enrollment

458

Registered

2012-04-17

Start date

2011-12-31

Completion date

2013-01-31

Last updated

2013-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Support

Keywords

(PN) Parenteral nutrition, oral/enteral not possible

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.

Interventions

OTHEROliclinomel 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

OTHERCompounded ternary parenteral nutrition admixtures

Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Serum Prealbumin	Serum Prealbumin at Day 5

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026