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

This study has been completed.
Information provided by (Responsible Party):
JW Pharmaceutical ( JW Life Science )
ClinicalTrials.gov Identifier:
First received: January 18, 2012
Last updated: February 15, 2013
Last verified: February 2013

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

Condition Intervention Phase
Drug: CombiflexOmega
Drug: SmofKabiven
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega and SmofKabiven in Postoperative Patients Requiring Parenteral Nutrition

Resource links provided by NLM:

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • Comparison of adverse drug reaction [ Time Frame: 6days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes of laboratory parameters (biochemistry, hematology, coagulation) [ Time Frame: 7days ] [ Designated as safety issue: Yes ]
  • Changes of vital signs [ Time Frame: 7days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CombiflexOmega Drug: CombiflexOmega
intravenously over 5 days infusion
Active Comparator: SmofKabiven Drug: SmofKabiven
intravenously over 5 days infusion


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533766

Korea, Republic of
Seoul National University Bundang Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Life Science
  More Information

No publications provided

Responsible Party: JW Pharmaceutical ( JW Life Science )
ClinicalTrials.gov Identifier: NCT01533766     History of Changes
Other Study ID Numbers: CW-CFO-302
Study First Received: January 18, 2012
Last Updated: February 15, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014