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

Parent Clinical Trial

— OMEGA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533766
• Other study ID #: CW-CFO-302
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2012
• Last updated: February 15, 2013
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2013
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parent

Intervention

Drug:
• CombiflexOmega
intravenously over 5 days infusion
• SmofKabiven
intravenously over 5 days infusion

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Life Science

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of adverse drug reaction		6days	Yes
Secondary	Changes of laboratory parameters (biochemistry, hematology, coagulation)		7days	Yes
Secondary	Changes of vital signs		7days	Yes