A Safety, Efficacy Study of CombiflexOmega Versus SmofKabiven in Patients With Parenteral Nutrition

A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega and SmofKabiven in Postoperative Patients Requiring Parenteral Nutrition

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01533766

Acronym

OMEGA

Enrollment

Registered

2012-02-15

Start date

2011-08-31

Completion date

2012-02-29

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parent

Brief summary

The purpose of this study is to compare the safety and efficacy of CombiflexOmega in comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.

Interventions

DRUGCombiflexOmega

intravenously over 5 days infusion

DRUGSmofKabiven

intravenously over 5 days infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 20 and older * Patients are expected to require PN for more than 5 days * Patients who voluntarily signed the consent form

Exclusion criteria

* Patients are expected difficult to survive more than 5 days * Pregnant or breast-feeding women * BMI \> 30 kg/m2 * Patients with severe blood coagulation disorders * Patients with congenital amino acid metabolism disorders * Patients with acute shock * Patients with uncontrollable diabetes mellitus * Patients with hemophage syndrome * Patients with hypopotassemia (K \< 3.0mEq/L) * Patients having the history of myocardial infarction * Patients reported the following laboratory value * fasting TG \> 250mg/dl, TC \> 300mg/dl * ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas) * Creatinine ≥ 1.5mg/dl * Ca \> 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L * Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug * Patients having the history of drug or alcohol abuse * General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation * Patients are in unstable conditions * Patients with difficult peripheral intravenous * Patients with parenteral nutrition within 7 days prior to start of the trial * Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study * Patients judged to be unsuitable for this trial by investigators

Design outcomes

Primary

Measure	Time frame
Comparison of adverse drug reaction	6days

Secondary

Measure	Time frame
Changes of laboratory parameters (biochemistry, hematology, coagulation)	7days
Changes of vital signs	7days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026