Skip to main content
OpenTrials
Completed

NCT Number: NCT01533298

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 20 and older
  • Patients are expected to require PN for more than 3 days
  • Patients who voluntarily signed the consent form

Exclusion criteria

  • Patients are expected difficult to survive more than 3 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

Treatment and study plan

CombiflexOmega peri

Drug

intravenously over 3 days infusion

SmofKabiven peripheral

Drug

intravenously over 3 days infusion

Primary outcomes

  1. Comparison of adverse drug reaction

    Time frame: 4days

Secondary outcomes

  1. Changes of laboratory parameters (biochemistry, hematology, coagulation)

    Time frame: 5days

  2. Changes of vital signs

    Time frame: 5days

Sponsors and collaborators

Lead sponsor

JW Life Science

Industry

Registry information

Official study title

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

Acronym: OMEGA

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Feb 15, 2012
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.