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

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ClinicalTrials.gov Identifier: NCT01533298
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : February 18, 2013
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical ( JW Life Science )

January 18, 2012
February 15, 2012
February 18, 2013
July 2011
December 2011   (Final data collection date for primary outcome measure)
Comparison of adverse drug reaction [ Time Frame: 4days ]
Same as current
Complete list of historical versions of study NCT01533298 on ClinicalTrials.gov Archive Site
  • Changes of laboratory parameters (biochemistry, hematology, coagulation) [ Time Frame: 5days ]
  • Changes of vital signs [ Time Frame: 5days ]
Same as current
Not Provided
Not Provided
 
A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral Nutrition
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parent
  • Drug: CombiflexOmega peri
    intravenously over 3 days infusion
  • Drug: SmofKabiven peripheral
    intravenously over 3 days infusion
  • Experimental: CombiflexOmega peri
    Intervention: Drug: CombiflexOmega peri
  • Active Comparator: SmofKabiven peripheral
    Intervention: Drug: SmofKabiven peripheral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
January 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01533298
CW-CFO-301
Not Provided
Not Provided
Not Provided
JW Pharmaceutical ( JW Life Science )
JW Life Science
Not Provided
Not Provided
JW Pharmaceutical
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP