Trials Sponsors Conditions Drugs Pricing

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

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

Sponsors & Collaborators

Baxter Healthcare Corporation
Industrylead

Study Sites (1)

Shanghai No. 6 Hospital

Shanghai, China

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

Enrollment

458 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

compounded ternary parenteral nutrition

Oliclinomel N4 formulation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

compounded ternary parenteral nutrition

Oliclinomel N4 formulation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations