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

JW Life Science

Status and phase: Completed; Phase 3

Conditions: Parent

Treatments: Drug: SmofKabiven; Drug: CombiflexOmega

Study type: Interventional

Funder types: Industry

Identifiers

NCT01533766

CW-CFO-302

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

CombiflexOmega

Experimental group

Treatment:

Drug: CombiflexOmega

SmofKabiven

Active Comparator group

Treatment:

Drug: SmofKabiven