- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01533766
A Safety, Efficacy Study of CombiflexOmega Versus SmofKabiven in Patients With Parenteral Nutrition (OMEGA)
February 15, 2013 updated by: JW Life Science
A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega and SmofKabiven in Postoperative Patients Requiring Parenteral Nutrition
The purpose of this study is to compare the safety and efficacy of CombiflexOmega in comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CombiflexOmega
|
intravenously over 5 days infusion
|
Active Comparator: SmofKabiven
|
intravenously over 5 days infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of adverse drug reaction
Time Frame: 6days
|
6days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes of laboratory parameters (biochemistry, hematology, coagulation)
Time Frame: 7days
|
7days
|
Changes of vital signs
Time Frame: 7days
|
7days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
January 18, 2012
First Submitted That Met QC Criteria
February 10, 2012
First Posted (Estimate)
February 15, 2012
Study Record Updates
Last Update Posted (Estimate)
February 18, 2013
Last Update Submitted That Met QC Criteria
February 15, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- CW-CFO-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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