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

NCT ID: NCT01533298

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-01-31

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.

Conditions

Parent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CombiflexOmega peri

Group Type: EXPERIMENTAL

CombiflexOmega peri

Intervention Type: DRUG

intravenously over 3 days infusion

SmofKabiven peripheral

Group Type: ACTIVE_COMPARATOR

SmofKabiven peripheral

Intervention Type: DRUG

intravenously over 3 days infusion

Interventions

CombiflexOmega peri

intravenously over 3 days infusion

Intervention Type: DRUG

SmofKabiven peripheral

intravenously over 3 days infusion

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JW Life Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CW-CFO-301

Identifier Type: -

Identifier Source: org_study_id