NCT01579097

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nutrition Support

Interventions

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

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2012-04-17
• Last updated: 2013-02-01

Locations

1 site across 1 country: China