Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical ( JW Life Science )
ClinicalTrials.gov Identifier:
NCT01533766
First received: January 18, 2012
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Parent
 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

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

  Eligibility

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

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

Locations
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 May 16, 2013