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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 )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parent Drug: CombiflexOmega peri Drug: SmofKabiven peripheral Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: CombiflexOmega peri Drug: CombiflexOmega peri
intravenously over 3 days infusion
Active Comparator: SmofKabiven peripheral Drug: SmofKabiven peripheral
intravenously over 3 days infusion



Primary Outcome Measures :
  1. Comparison of adverse drug reaction [ Time Frame: 4days ]

Secondary Outcome Measures :
  1. Changes of laboratory parameters (biochemistry, hematology, coagulation) [ Time Frame: 5days ]
  2. Changes of vital signs [ Time Frame: 5days ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533298


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

Responsible Party: JW Life Science
ClinicalTrials.gov Identifier: NCT01533298     History of Changes
Other Study ID Numbers: CW-CFO-301
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013