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Completed

NCT Number: NCT01579097

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

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.

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Key information

Conditions

Nutrition Support Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai No. 6 Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oliclinomel N4

Other

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

Compounded ternary parenteral nutrition admixtures

Other

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

Primary outcomes

  1. Serum Prealbumin

    Time frame: Serum Prealbumin at Day 5

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 17, 2012
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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