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

NCT01579097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2013-02-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Baxter Investigative Site · Shanghai, China

  • Baxter Investigative Site · Shantou, China

  • Baxter Investigative Site · Haikou, China

  • Baxter Investigative Site · Jiangsu Province, China

  • Baxter Investigative Site · Beijing, China

  • Baxter Investigative Site · Changsha, China

  • Baxter Investigative Site · Hangzhou, China

  • Baxter Investigative Site · Nanning, China

  • Baxter Investigative Site · Shang dong Province, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-11-30
Completion
2013-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01579097 on ClinicalTrials.gov