NCT01579097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

April 13, 2012

Last Update Submit

January 31, 2013

Conditions

Nutrition Support

Keywords

(PN) Parenteral nutritionoral/enteral not possible

Outcome Measures

Primary Outcomes (1)

  • Serum Prealbumin

    Serum Prealbumin at Day 5

Study Arms (2)

compounded ternary parenteral nutrition

ACTIVE COMPARATOR

compounded ternary Parenteral Nutrition admixture

Other: Compounded ternary parenteral nutrition admixtures

Oliclinomel N4 formulation

EXPERIMENTAL

Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag

Other: Oliclinomel N4

Interventions

Oliclinomel N4OTHER

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

Also known as: Oliclinomel N4-550
Oliclinomel N4 formulation
Compounded ternary parenteral nutrition admixturesOTHER

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

compounded ternary parenteral nutrition

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai No. 6 Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Baxter Investigative Site

    Shanghai, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Shantou, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Haikou, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Jiangsu Province, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Beijing, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Changsha, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Hangzhou, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Nanning, China

    STUDY DIRECTOR

  • Baxter Investigative Site

    Shang dong Province, China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 17, 2012

Study Start

December 1, 2011

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

CN(1)