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

Sponsor
JW Life Science (Industry)
Overall Status
Completed
CT.gov ID
NCT01533766
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
6
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 and SmofKabiven in Postoperative Patients Requiring Parenteral Nutrition
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: CombiflexOmega

Drug: CombiflexOmega
intravenously over 5 days infusion
Active Comparator: SmofKabiven

Drug: SmofKabiven
intravenously over 5 days infusion

Outcome Measures

Primary Outcome Measures

  1. Comparison of adverse drug reaction [6days]

Secondary Outcome Measures

  1. Changes of laboratory parameters (biochemistry, hematology, coagulation) [7days]

  2. Changes of vital signs [7days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • JW Life Science

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JW Life Science
ClinicalTrials.gov Identifier:
NCT01533766
Other Study ID Numbers:
  • CW-CFO-302
First Posted:
Feb 15, 2012
Last Update Posted:
Feb 18, 2013
Last Verified:
Feb 1, 2013

Study Results

No Results Posted as of Feb 18, 2013